MBRCC Cancer Clinical Trials:

• Ancillary Cancer
• Breast Cancer
• Colorectal Cancer
• Hematologic
• Leukemia
• Lung Cancer
• Melanoma
• Other Studies
• Prostate Cancer
• Rectum Cancer
• Renal Cancer

Ancillary

Evaluation of Molecular Abnormalities of Potential Relevance to the Efficacy of Targeted Anticancer Treatment in Lung and Head & Neck Cancers (EGFR)

Objectives

1. Primary Objectives:
   • To assess the time taken from sample receipt to availability of final tumor molecular abnormality lab data for each patient.
   • To investigate the EGFR-gene mutations, EGFR- protein activation, and EGFRexpression in all patients with non-small cell lung cancer and head and neck cancer, undergoing surgical resection or diagnostic biopsy.
2. Secondary Objectives:
   • To evaluate relationships between tumor molecular abnormalities and anti-tumor response rate to epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKI's); Iressa and Tarceva in patients with non-small cell lung cancer or head & neck cancer, in case that the blinded treating physician decide to treat the patients with EGFR-TKI's.
   • To evaluate progression free survival and overall survival in patients mentioned above.

Eligibility

1. At least 18 years old
2. Signed informed consent
3. All patients with non-small cell lung cancer or head & neck cancer
4. Evaluable disease

For more information about this trial, please contact the Study Coordinator.

Contacts

Ramin Altaha, MD, Principal Investigator
(304) 293-4229, raltaha@hsc.wvu.edu

Slyvia Mcewuen, Study Coordinator
(304) 293-1683, smcewuen@hsc.wvu.edu

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Breast Cancer

Bone Marrow Analysis in Early Stage Breast Cancer (NSABP BP-59).

Objectives
Primary aim and endpoint

The primary aim is to determine the relative risk of death associated with the presence of
tumor cells in the bone marrow of patients with early-stage breast cancer.

The primary endpoint for analysis is overall survival (OS), where OS will be the time
from entry into the study to death from any cause.

Secondary aim and endpoint

The secondary aim is to investigate the relationship between the two tumor cell detection
methods, bright-field and multicolor fluorescence immunocytochemistry, in detecting
bone marrow micrometastasis.

The secondary endpoint for the analysis will be the tumor cell presence in bone marrow
as detected by the bright-field and multicolor fluorescence immunocytochemical
methods.

Eligibility
Only patients who satisfy all the following conditions will be considered eligible for the study.
 

1. The patient must have consented to participate and must have signed an appropriate IRB-approved consent form that conforms to federal and institutional guidelines.
2. Histologic diagnosis of invasive adenocarcinoma of the breast diagnosed by core,
   incisional, or excisional biopsy.
3. All of the following staging criteria must be met:
   • Primary tumor must be operable and staged as cT1-3 by clinical evaluation.
   • Ipsilateral nodes must be cN0-1 by clinical evaluation.
   • No evidence of metastatic disease (M0).

For more information about this trial, please contact the Study Coordinator.

Contacts
Hannah Hazard, MD, Principal Investigator
(304) 293-2380, hhazard@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

A Phase III Study of SU011248 in Combination with Paclitaxel versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer (A6181094)

Objectives
The purpose of this clinical trial is to test whether treatment of patients with breast cancer with SU011248 plus paclitaxel is better than treatment with bevacizumab plus paclitaxel.

Eligibility
Patients meeting all of the following criteria will be considered eligible for enrollment into the study:

1.Histologically or cytologically proven diagnosis of breast cancer with evidence of 1)
unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amenable to resection OR radiation therapy with curative intent.

2.Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.

3.Male or female, 18 years of age or older.

4. ECOG performance status 0 or 1.

5. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade ≤1 (except alopecia).

6. Adequate organ function as defined by the following criteria:

• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin ≤1.5 x ULN
• Serum albumin ≥3.0 g/dL
• Absolute neutrophil count (ANC) ≥1500/μL
• Platelets ≥100,000/μL
• Hemoglobin ≥9.0 g/dL
• Serum creatinine ≤1.5 x ULN
• Urine protein:creatinine ratio <1
• Left ventricular ejection fraction (LVEF) above the lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).

7.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.

8.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

For more information about this trial, please contact the Study Coordinator.
Contacts

Jame Abraham, MD, Principal Investigator
(304) 293-4229, jabraham@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpable and Operable HER2 Positive Breast Cancer Comparing the Combination of Trastuzumab and to Lapatinib Administered with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response (NSABP B-41)

Objectives
The primary aims of the study are: 1) to determine whether the regimen of AC followed by weekly paclitaxel (WP) plus trastuzumab plus lapatinib yields a greater rate of pCR in the breast than the regimen of AC followed by WP plus trastuzumab and 2) to determine whether the regimen of AC followed by WP plus lapatinib yields a greater rate of pCR in the breast than the regimen of AC followed by WP plus trastuzumab.

A secondary aim for this study is determining whether AC followed by WP plus trastuzumab plus
lapatinib yields a greater rate of pCR in the breast than AC followed by WP plus lapatinib.
Secondary aims also include corresponding comparisons of rates of pCR in the breast and nodes;
clinical overall response rates; clinical complete response rates; recurrence-free interval; overall
survival; and evaluation of cardiac and non-cardiac toxicities of each treatment regimen.

Eligibility
A patient cannot be considered eligible for this study unless all of the following conditions are met.

1. The patient must have consented to participate and must have signed and dated
an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and release of the required block from the diagnostic core biopsy for the B-41 correlative studies. Prior to study entry, the local pathology department must have agreed to release the block. (Note: The block must be submitted within 30 days following randomization.)

2. Patients must be female.

3.Patients must be 18 years of age or older.

4.Patients must have an ECOG performance status of 0 or 1 (0 = fully active, able
to carry on all pre-disease performance without restriction; 1 = restricted in
physically strenuous activity but ambulatory).

5. The primary breast tumor must be palpable and measure ≥ 2.0 cm by physical
exam.

6.The diagnosis of invasive adenocarcinoma of the breast must have been made by
core needle biopsy.

7.The breast cancer must be determined to be HER2-positive prior to study entry.
Assays using FISH require gene amplification. Assays using IHC require a
strongly positive (3+) staining score.

8.  All patients must have an LVEF assessment by MUGA scan or echocardiogram
within 3 months prior to randomization. The LVEF must be ≥ 50% regardless of
the facility's LLN.

Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent
LVEF assessments to determine if trastuzumab and/or lapatinib can be
administered, it is critical that this baseline study be an accurate assessment of
the LVEF. If the baseline LVEF is > 65%, the study should be reviewed for
accuracy prior to study entry. Following study entry, the LVEF determination
may be reviewed up until the time of the post-AC evaluation.

9. At the time of randomization, blood counts must meet the following criteria:

• ANC must be ≥ 1200/mm3
• Platelet count must be ≥ 100,000/mm3
• Hemoglobin must be ≥ 10 g/dL

10. Serum creatinine must be ≤ ULN for the lab.

11. There must be evidence of adequate hepatic function by these criteria:

• Total bilirubin must be ≤ the ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN resulting from Gilbert’s disease or similar syndrome due to slow conjugation of bilirubin; and
• Alkaline phosphatase must be ≤ 2.5 x ULN for the lab; and
• AST must be ≤ 1.5 x ULN for the lab.

12. Patients with either skeletal pain or alkaline phosphatase that is > ULN (but
≤ 2.5 x ULN) are eligible for inclusion in the study if bone scan or PET scan does
not demonstrate metastatic disease. Suspicious findings on scan must be
determined to be benign by x-ray, MRI, or biopsy.

13.Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the
study if liver imaging (CT, MRI or PET scan) does not demonstrate definitive
metastatic disease and the requirements in criterion 4.2.11 are met.

14. Patients must be able to swallow oral medications.

For more information about this trial, please contact the Study Coordinator.
Contacts

Jame Abraham, MD, Principal Investigator
(304) 293-4229, jabraham@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

Cognitive Function in Cancer Chemotherapy (CFCC)

Objectives

Primary

• To determine the frequency and nature of cognitive deficits in patients receiving treatment for breast or colorectal cancer

Secondary

• To collect samples for future evaluation of genes which may impact on the frequency or severity of cognitive deficits.

Eligibility

1. We will include all newly diagnosed breast and colorectal cancer patients who are expected to receive chemotherapy and/or hormone therapy and have not received prior chemotherapy treatment for cancer.
2. Prior surgical and/or radiation treatment (excluding radiation to the brain) will not be exclusionary.
3. We will include all stages of disease for both groups of patients.
4. Metastatic patients will be included as long as metastases do not involve the brain.
5. Both males and females will be eligible to participate.
6. Individuals age 18 and older will be eligible to participate.
7. All patients regardless of life expectancy will be eligible to participate.
8. We will not exclude subjects based on use of psychotropic medications, such as benzodiazepines, but will record the use of such medications and treat it as a covariate in the analysis.

For more information about this trial, please contact the Study Coordinator.

Contacts

Marc Haut, PhD, Principal Investigator
(304) 293-5955, mhaut@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial

Objectives

Primary

1. To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the "primary study group" category (Oncotype DX Recurrence Score 11-25). The primary study endpoint is disease-free survival; other co-primary endpoints include distant recurrence free interval, recurrence free interval, and overall survival as defined in Section 6.
2. To create a tissue and specimen bank for patients enrolled in this trial, including formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and DNA obtained from peripheral blood. This resource will be critical for evaluating emerging Clinical Cancer Tests.

Secondary

1. To determine whether adjuvant hormonal therapy is sufficient treatment (i.e. 10 year distant disease-free survival of at least 95%) for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the "Secondary Study Group-1" category (Oncotype DX Recurrence Score < 10). The primary study endpoint is disease-free survival; other co-primary endpoints include distant recurrence free interval, recurrence free interval, and overall survival as defined in Section 6.
2. To compare the outcomes projected at 10 years by Adjuvant! (with outcomes projected using classical pathologic information including tumor size, hormone receptor status, and histologic grade) with those made by the Genomic Health Oncotype DX test. Classical pathologic information and outcome results will also be used to create and refine models that would use classical information instead of or in combination with genomic tests.
3. To estimate failure rates as a function of RS separately in the chemotherapy (arms C, D) and no chemotherapy (arms A, B) groups. The purpose of the analysis is to develop more precise estimates of the relationship between recurrence score and chemotherapy treatment effect, if any, at the upper range of the RS 11 - 25 group.
4. To determine the prognostic significance of the Oncotype DX recurrence score and of the individual RS gene groups (proliferation gene group, HER2 gene group, ER gene group, invasion gene group, and other genes).

Eligibility

Each of the criteria in the following section must be met in order for a patient to be considered eligible for this study. Use the spaces provided to confirm a patient's eligibility. For each patient, this section should be photocopied, completed and maintained in the patient's chart.

NOTE: This study involves a pre-registration and a registration/randomization (see Section 4). All time frames for prestudy scan and lab values and other requirements will be based on the date of pre-registration.

NOTE: Institutions may use the eligibility checklist as source documentation if it has been reviewed, signed, and dated prior to registration/randomization by the treating physician.

NOTE: Questions regarding eligibility should be directed to the ECOG Study Chair, Joseph Sparano, M.D., at (718) 904-2555, the Study Chair Liaison, Una Hopkins, at (718)-405-8522 or the CTSU Help Desk at 1-888-823-5923.

1. Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment and meet the following criteria.
• ER and/or PR-positive
• Negative axillary nodes
• Tumor size 1.1-5.0cm (or 5 mm-1.0 cm plus unfavorable histological features): Unfavorable features defined as intermediate or poor nuclear and/or histologic grade, or lymphovascular invasion.
  NOTE: Definition of tumor size: The tumor size used for determination of eligibility is the pathologic tumor size, which is usually determined by the size of the tumor as measured by inspection of the gross specimen. If the tumor size is measured microscopically and the tumor includes ductal carcinoma in-situ, the measurement should include only the invasive component of the tumor.
• The tumor must be Her2/neu negative by either fluorescent in-situ hybridiation (FISH) or immunohistochemistry (e.g. 0 or 1+ by DAKO Herceptest).
2. The patient and physician must be agreeable to initiate standard chemotherapy and hormonal therapy as adjuvant therapy. The standard chemotherapy and hormonal therapy options permitted are described in Appendix II and Appendix III.
3. A tissue specimen from the primary breast cancer has been located and is ready to be shipped to the appropriate laboratory after consent is obtained and within 3 days following pre-registration as indicated in Section 10.
   NOTE: For determination of the Oncotype Recurrence Score, tissue must be shipped to Genomic Health. If the Oncotype DX Recurrence Score was previously performed by Genomic Health (prior to pre-registration), tissue must be submitted to the ECOG Pathology Coordinating Office upon randomization.
4. Patients must be =18 years and = 75 years. Patients must be less than 76 years of age because patients will be followed for up to 20 years, and because the primary study endpoints are based upon a 10 year endpoint.
5. Patients must have adequate organ function, including the following within 4 weeks prior to pre-registration:
• Leukocyte count = 3500/ mm3 and platelets = 100,000/mm3.
• Serum creatinine = 1.5mg/dL.
• Serum aspartate transaminase (AST) that is = 3-fold the upper institutional limits of normal.
6. Patients must be disease-free of prior invasive malignancies for = 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with a previous ipsilateral or contralateral invasive breast cancer, or with bilateral synchronous cancers, are not eligible. Patients with previous ipsilateral or contralateral DCIS are not eligible.
7. Prior Treatment:
• Mandatory prior surgery criteria:
1. Patient must pre-register within 84 days from the final surgical procedure required to adequately treat the primary tumor.
2. All tumors should be removed by either a modified radical mastectomy or local excision plus an acceptable axillary procedure (i.e., sentinel lymph node biopsy, axillary dissection, or both). There must be adequate (at least 1 mm, i.e. > 1 mm, if margin width specified) tumor-free margins of resection (for invasive and ductal carcinoma in-situ) in order for the patients to be eligible. Patients with lobular carcinoma in-situ involving the resection margins are eligible.
• Criteria re: other prior treatments:
1. No prior chemotherapy for this malignancy.
2. No prior radiation therapy for this malignancy.
3. Hormonal therapy: Patients who develop breast cancer while receiving a selective estrogen-receptor modulator (SERM; e.g., tamoxifen, toremifene, raloxifene) or an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane) for breast cancer prevention or a SERM for other indications (e.g., raloxifene for osteoporosis) are not eligible. However, patients may have received up to 8 weeks of a SERM or aromatase inhibitor for this malignancy and still be eligible for study entry.
8. Patients must have an anticipated life expectancy of at least 10 years. Patients with the following medical conditions should not be enrolled on the study:
• Chronic obstructive pulmonary disease requiring treatment.
• Chronic liver disease (e.g., cirrhosis, chronic active hepatitis)
• Previous history of a cerebrovascular accident.
• History of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline (e.g., doxorubicin or epirubicin).
• Chronic psychiatric condition or other condition that would impair compliance with the treatment regimen.
9. Women must not be pregnant or breast-feeding due to the potential use of cytotoxic chemotherapy for patients participating in this trial, which is contraindicated due to the potential for chemotherapy to cause harm to the fetus or infant. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to pre-registration to rule out pregnancy.
• Women of childbearing potential must be strongly advised to utilize an accepted and effective form of non-hormonal contraception (e.g. intrauterine device, condoms, diaphragm, abstinence).
10. Patients must not have previously had the Oncotype DX Assay performed, with the exception of patients who have had the assay performed and have a Recurrence Score of 11-25.
    NOTE: A copy of the "Oncotype DX Patient Report" is to be faxed to the ECOG Coordinating Center (Fax: 617-582-8578, Attn: Pre-registration/PACCT-1) upon receipt of the report, or, if Oncotype DX Assay was previously performed, immediately following pre-registration. The protocol number (PACCT-1), and pre-registration sequence number MUST be indicated on the report.

For more information about this trial, please contact the Study Coordinator.

Contacts

Jame Abraham, MD, Principal Investigator
(304) 293-4229, jabraham@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer (NSABP B-42)

Objectives

The primary aim is to determine whether or not prolonged adjuvant hormonal therapy with letrozole will improve disease-free survival in postmenopausal women with ER-positive and/or PgR-positive tumors who have completed 5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a combination of up to 3 years of tamoxifen followed by an AI.

Eligibility

Patients who satisfy all of the following conditions are the only patients who will be considered eligible for the study:

1. The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines.
2. Patients must be female.
3. Patients must have an ECOG performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory).
4. Patients must be postmenopausal at the time of randomization. (Note: Premenopausal or perimenopausal women requiring therapy with luteinizing hormone-releasing hormone [LHRH] analogs to suppress ovarian function are not eligible.)
   
   For study purposes, postmenopausal is defined as:
• age 56 or older with no spontaneous menses for at least 12 months prior to study entry, or
• age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) AND with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standards, or
• a prior documented bilateral oophorectomy.
  
5. The patient must have remained disease-free from the time of initial breast cancer diagnosis until the time of randomization.
6. The primary tumor must have been pathologic or clinical stage I, II, or IIIA invasive carcinoma of the breast documented by core needle or open biopsy. (Refer to Coordinator Online in the Members' Area of the NSABP Web site for TNM nomenclature and staging information.)
7. The primary tumor must have been ER-positive and/or PgR-positive. (Patients who had a tumor that was considered to be borderline for ER positivity and who were treated with tamoxifen and/or an AI are eligible for this study.)
8. Patients must have undergone either a lumpectomy with axillary nodal staging followed by breast radiotherapy or a total mastectomy with axillary nodal staging. (Acceptable axillary nodal staging procedures include sentinel node biopsy alone, if sentinel nodes were negative on H&E staining.)
9. The duration of the patient's hormonal therapy following breast cancer diagnosis must have been 57-63 months from the first dose regardless of the number of missed doses. Hormonal therapy must have consisted of an AI or a combination of up to 3 years of tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 and 5 of the 5 years of adjuvant hormonal therapy.
   Optional Letrozole Registration Program for patients who have not yet completed 5 years of hormonal therapy: In order to have a predominantly letrozole-treated population for B-42 study entry, patients who have had a minimum of 2 years of hormonal therapy and who are currently on tamoxifen (for up to 3 years) or an AI may be offered letrozole at no cost until they complete 5 total years of initial adjuvant hormonal therapy. See Appendix A for instructions on enrolling patients on this optional Letrozole Registration Program.
10. B-42 randomization must be within 6 months following completion of 5 years of initial adjuvant homonal therapy.
11. At the time of randomization, the patient must have had the following:
    • history and physical exam within 3 months demonstrating no findings suggestive of recurrent breast cancer;
    • bilateral mammogram within 1 year (unilateral if patient had a mastectomy);
    • bone mineral density (BMD) testing within 1 year; and
    • lipid profile (total cholesterol, LDL-C, HDL-C, and triglycerides) with a total cholesterol value = grade 1 (according to CTCAE v3.0), with or without cholesterol-lowering therapy.
      
      • within 1 year if the patient has a history of hypercholesterolemia controlled with cholesterol-lowering therapy and/or therapeutic lifestyle changes or if the patient has a history of one or more of the following risk factors for future cardiovascular events: diabetes, hypertension, obesity, tobacco use, hypertriglyceridemia, documented coronary artery disease, or family history of premature coronary heart disease.
      • within 2 years for all other patients.

For more information about this trial, please contact the Study Coordinator.

Contacts

Jame Abraham, MD, Principal Investigator
(304) 293-4229, jabraham@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophophamide (AC), with or without Celecoxib, in Patients with Node-Negative Breast Cancer (NSABP B-36)

Objectives

Our primary aim is to determine superiority among the proposed regimens for prolonging disease-free survival (DFS) in women with node-negative, hormone-receptor-positive or negative breast cancer. To this end we will determine:

• Whether a regimen of six cycles of 5-FU, epirubicin, and cyclophosphamide (FEC100) is superior to four cycles of AC in prolonging DFS in this group of women.
• Whether chemotherapy (AC or FEC-100) plus celecoxib is superior to chemotherapy alone in prolonging DFS in the same group of women.

Eligibility

Female patients who satisfy all of the following conditions are the only patients who will be eligible for this study:

1. The patient must consent to participate in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
2. The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions and performance status should be taken into consideration, but not the diagnosis of breast cancer.)
3. The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, sentinel lymph node biopsy, axillary surgery, or re-excision of lumpectomy margins) and randomization must be no more than 84 days.
4. The tumor must be invasive adenocarcinoma on histologic examination. (Patients with tumors that are pure tubular or mucinous adenocarcinomas are not eligible.)
5. The primary tumor must be T_1-3 by clinical and pathologic evaluation.
6. Lymph nodes obtained from all axillary staging procedures must be histologically negative by standard H&E staining. (Patients with nodes that are positive by immunohistochemistry but negative by standard H&E staining are eligible.)
7. Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER is negative, then progesterone receptor (PgR) analysis must be performed. If ER is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results [i.e., those not definitively negative] will be considered positive regardless of the methodology used.)
8. Patients must have had either a lumpectomy or total mastectomy.
9. Patients must have undergone axillary nodal staging procedures, for example sentinel node (SN) biopsy alone, SN biopsy followed by axillary sampling or completion dissection, or axillary node dissection to obtain lymph nodes for pathologic evaluation. If the patient has palpable nodes, axillary dissection is required.
10. Patients must have no clinical or radiologic evidence of metastatic disease.
11. Patients with skeletal pain are eligible for inclusion in the study if bone scan or roentgenological examination fail to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.
12. The patient's menopausal status must be determined prior to randomization. Pre- and postmenopausal women are eligible. The following criteria will be used to define postmenopausal:
    • a prior documented bilateral oophorectomy, or
    • a history of at least 12 months without spontaneous menstrual bleeding, or
    • age 55 or older with a prior hysterectomy or
    • age 54 or younger with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the lab's postmenopausal range.
      
      Women failing to meet one of these criteria will be classified as premenopausal.
      
      
13. At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; bilateral mammogram within the past 6 months; and pelvic exam (for women who have a uterus and who will be receiving tamoxifen) within the past year.
14. Within 3 months prior to entry, the patient must have a baseline LVEF measured by MUGA scan or echocardiogram equal to or greater than the lower limit of normal for the facility performing the procedure.
15. At the time of randomization:
    • The postoperative absolute granulocyte count (AGC) must be ≥ 1500/mm³ (or ≥ 1200/mm³ if, in the opinion of the investigator, this represents an ethnic or racial variant of normal).
    • Postoperative platelet count must be ≥ 100,000/mm³. Significant underlying hematologic disorders must be excluded when the platelet count is above the ULN for the lab.
    • There must be postoperative evidence of adequate hepatic function, i.e.,
      • total bilirubin must be ≤ ULN for the lab unless the patient has a chronic Grade 1 bilirubin elevation (> ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
      • alkaline phosphatase must be < 2.5 x ULN for the lab; and
      • the AST [SGOT] must be ≤ 1.5 x ULN for the lab.
    • There must be postoperative evidence of normal renal function (serum creatinine ≤ ULN).
16. Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
17. The patient must be willing to abstain from chronic use of all NSAIDs, COX-2 inhibitors, and salicylates excluding cardioprotective low dose aspirin (for example ≤ 81 mg/day or 325 mg QOD) for the duration of the celecoxib/placebo. Chronic use of NSAIDs and aspirin is defined as use for more than an average of 3 days per month.

For more information about this trial, please contact the Study Coordinator.

Contacts

Jame Abraham, MD, Principal Investigator
(304) 293-4229, jabraham@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

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Breast Cancer

A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens (NSABP B-40)

Objectives

Primary
To determine whether the combination of docetaxel/capecitabine→AC or docetaxel/gemcitabine→AC, with or without bevacizumab, will increase the rate of pathologic complete response in the breast (pCR breast) relative to docetaxel→AC with or without bevacizumab.  

Secondary
To determine whether the addition of bevacizumab to the docetaxel/anthracyclinebased regimens (docetaxel→AC, docetaxel/capecitabine→AC, and docetaxel/gemcitabine→AC) will increase the rate of pCR breast relative to the same docetaxel/anthracycline-based regimens without bevacizumab.

Eligibility

1. The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of pre-entry core biopsy material for correlative studies.
2. Patients must be female.
3. Patients must be 18 years of age or older.
4. Patients must have an ECOG performance status of 0 or 1.
5. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
6. The primary breast tumor must be palpable and measure ≥ 2.0 cm.
7. All patients must have their left ventricular ejection fraction (LVEF) assessed by MUGA scan or echocardiogram within 3 months prior to study entry. The LVEF must be ≥ the lower limit of normal (LLN) for the cardiac imaging facility performing the study.
   
   Note: If the cardiac imaging facility cannot provide a LLN, use 50% as the LLN value.
   
   
   Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued, it is critical that this baseline study be an accurate assessment of the patient’s LVEF. If the baseline LVEF is > 75%, the investigator should have the study reviewed for accuracy prior to study entry. Following study entry, the LVEF determination may be reviewed up until the time of the post-chemotherapy (preoperative) evaluation. Please note that if a more accurate value is obtained from the review of the baseline MUGA or echocardiogram, the correct value must be submitted to the NSABP before the post-chemotherapy (preoperative) MUGA or echocardiogram is performed or it cannot be used for managing postoperative bevacizumab.
   
   
8. All patients must have an EKG within 3 months prior to study entry.
9. At the time of randomization:
• Absolute neutrophil count (ANC) must be ≥ 1200/mm3.
• Platelet count must be ≥ 100,000/mm3.
• Hemoglobin must be ≥ 10 g/dL.
• There must be evidence of adequate hepatic function by these criteria:
• Total bilirubin must be ≤ the ULN for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) resulting from Gilbert’s disease or similar syndrome due to slow conjugation of bilirubin; and
• Alkaline phosphatase must be ≤ 2.5 x ULN for the lab
• AST must be ≤ 1.5 x ULN for the lab (refer to Section 5.2.11)
• Alkaline phosphatase and AST may not both be > the ULN. For example, if the alkaline phosphatase is > the ULN but ≤ 2.5 x ULN, then the AST must be ≤ the ULN. If the AST is > the ULN but ≤ 1.5 x ULN, then the alkaline phosphatase must be ≤ ULN.
10. Patients with either skeletal pain or alkaline phosphatase that is > ULN but ≤ 2.5 x ULN are eligible for inclusion in the study if bone scans do not demonstrate metastatic disease. Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy.
11. Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging does not demonstrate metastatic disease and the requirements in criterion 5.2.9 are met.
12. The following criteria for evidence of adequate renal function must be met:
    • Serum creatinine ≤ ULN for the lab.
    • Calculated creatinine clearance must be > 50 mL/min
13. Urine protein/urine creatinine (UPC) ratio must be < 1.0.
14. Patient must be able to swallow oral medications.

For more information about this trial, please contact the Study Coordinator.

Contacts


Jame Abraham, MD, Principal Investigator
(304) 293-4229, jabraham@hsc.wvu.edu


Shannon Filburn, Study Coordinator
(304) 293-2745, sfilburn@hsc.wvu.edu

 

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COLORECTAL CANCER

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Colorectal Cancer

A Randomized Phase III Study Comparing 5-FU, Leucovorin, and Oxaliplatin vs. 5-FU, Leucovorin, Oxaliplatin, and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers (ECOG 5202)

Objectives

1. The primary objective is to demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU, leucovorin, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab.
2. Secondary objectives:
   • To compare overall survival between the regimens.
   • To further define the toxicity profiles of the regimens.
   • To prospectively determine the impact of tumor biological characteristics on the survival of patients with stage II colon cancer.

Eligibility

NOTE: All questions regarding eligibility should be directed to the ECOG Coordinating Center at (617) 632-3610.

NOTE: Institutions may use the eligibility checklist as source documentation if it has been reviewed, signed and dated prior to registration/randomization by the treating physician.

For more information about this trial, please contact the Study Coordinator.

Contacts

Sobha Kurian, MD, Principal Investigator
(304) 293-4229, skurian@hsc.wvu.edu

Dawn Scopel , Study Coordinator
(304) 293-7375,dscopel@hsc.wvu.edu

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Colorectal Cancer

A Randomized Phase III Trial of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer (NO147)

Objectives

1. To compare the overall survival in three groups of patients with stage III (T_xN_1-2M₀) colon cancer randomized to 24 weeks of adjuvant chemotherapy with either: (1) Oxaliplatin (OXAL) + 5-fluorouracil/leucovorin (5-FU/LV) (FOLFOX), (2) Irinotecan (CPT-11), 5-FU/LV (FOLFIRI), or (3) 6 cycles of FOLFOX followed by 6 cycles of FOLFIRI.
2. To compare the overall survival in the two groups of patients with stage III (T_x, N_1-2, M_O) colon cancer randomized to 24 weeks of adjuvant chemotherapy with or without cetuximab (C225).

Eligibility

Required Characteristics

1. Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal verge by rigid proctoscopy (i.e., patients with rectal cancer are not eligible). A rigid proctoscopy will be performed in only those settings where it is important to establish if the tumor is a rectal tumor or a colon tumor. Tumor must have been completely resected. In patients with tumor adherence to adjacent structures en bloc resection must be documented in the operative report. Patients with tumor-related obstruction or colonic perforation are eligible for enrollment.
2. At least one pathologically confirmed positive lymph node identified.
3. There must be no evidence of residual involved lymph node disease. At least one lymph node must be found in the pathologic specimen. To help ensure optimal stratification, the recommended number of identified nodes is four or more.
4. Evidence of Epidermal Growth Factor Receptor (EGFR) in the resected tumor is NOT required.
5. Randomization must occur ≤ 56 days postsurgery.
6. Patients with ≥ one synchronous primary colon cancer are eligible. For the purposes of this protocol, staging classifications will be based on the stage of the more advanced primary tumor.
7. ECOG performance status (PS) 0, 1, or 2 .
8. Age ≥ l8 years.
9. Laboratory values obtained ≤ 14 days prior to randomization:
   • Hgb ≥ 9 g/dL
   • Absolute neutrophil count ≥ LNL
   • Platelet count ≥ 100,000/µl
   • Creatinine ≤ 1.5 x UNL
   • Total bilirubin ≤ UNL
10. English speaking participants must have the ability to complete questionnaire(s) by themselves or with assistance. (All patients are allowed on study, but questionnaire(s) will only be available in English.)
11. Must provide tissue and blood samples. Patient has the right to later withdraw consent for research studies on blood or tissue specimens.

Contraindications

1. Any of the following:
   • Pregnant women
   • Nursing women
   • Men or women of childbearing potential who are unwilling to employ adequate contraception.
     
     This study involves agents (cetuximab, oxaliplatin, irinotecan and 5-fluorouracil whose teratogenic effects on the developing fetus and newborn are unknown.
     
2. Evidence of residual involved lymph node disease. ≥ 1 lymph node must be found in the pathologic specimen. To help ensure optimal stratification the recommended number of identified nodes is ≥ 4.
3. Distant metastatic disease at the time of randomization.
4. Prior chemotherapy or radiation therapy for treatment of this malignancy.
5. Prior therapy with agent(s) directed against EGFR.
6. Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
7. Previous or concurrent malignancy. Exceptions: Treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma in situ in one breast, or other cancer for which the patient has been disease-free ≥ 5 years.
8. Any of the following conditions:
   • Uncontrolled high blood pressure
   • Unstable angina
   • Symptomatic congestive heart failure
   • Myocardial infarction ≤ 6 months prior to randomization
   • New York Heart Association classification III or IV
   • Symptomatic pulmonary fibrosis or interstitial pneumonitis
   • Active uncontrolled bacterial, viral (including HIV or clinically defined AIDS)
   • Fungal infection
9. Other medical condition which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
10. Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI Common Terminology Criteria for Adverse Events, [CTCAE] v3.0 as ≥ grade 2 neurosensory or neuromotor toxicity).
11. Concurrent use of other anti-cancer therapy including chemotherapy agents, targeted agents, or biological agents.
12. Patients currently receiving ketoconazole or other potent inhibitors or CYP3A4 (e.g., intraconazole, voriconzaole). Ketoconazole has been shown to significantly increase the level of the active metabolite of CPT11 (95).

For more information about this trial, please contact the Study Coordinator.

Contacts

Sobha Kurian, MD, Principal Investigator
(304) 293-4229, skurian@hsc.wvu.edu

Dawn Scopel , Study Coordinator
(304) 293-7375,dscopel@hsc.wvu.edu

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HEMATOLOGIC

Hematologic (Non-Malignant)

Examination of PNH, by Level Of CD59 on REd and white blood cells, in bone marrow failure syndromes (EXPLORE)

** This study is an observational prevelance study.

Objectives

1. Primary Objectives:
   • To determine the occurrence of Paroxysmal Nocturnal Hemoglobinuria (PNH) cells in people with Aplastic Anemia (AA), Myelodysplastic Syndromes (MDS), and other bone marrow failure syndromes.
2. Secondary Objectives:
   • To understand the relationship between different bone marrow failure syndromes and the different characteristics of PNH.

Eligibility

Patients meeting all the following criteria will be considered for this study:

1. Is at least 18 years of age
2. Is willing to comply with the protocol
3. Is willing and able to give written informed consent
4. Has AA, MDS, or other bone marrow failure syndromes

For more information about this trial, please contact the Study Coordinator.

Contacts

Edward B. Crowell, MD, Principal Investigator
(304) 293-4229, ecrowell@hsc.wvu.edu

Tammy Clark, Study Coordinator
(304) 293-5264, tclark@hsc.wvu.edu

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LEUKEMIA

Leukemia

A Phase II Study of MOAD (Methotrexate, Vincristine, L-Asparaginase and Dexamethasone) with Subcutaneous Campath for Adults with Relapsed or Refractory Acture Lymphocytic Leukemia (ECOG 1904)

Objectives

1. The purpose of this study is to evaluate the safety and effectiveness of treating acute lymphocytic leukemia (ALL) patients with Methotrexate, Vincristinem L-asparaginase, Dexamethasone and Campath.

Eligibility

1. Patients must be in first relapse of acute lymphocytic leukemia or have failed to achieve complete remission with one prior regimen.
2. Patients with a history of CNS leukemia must have a normal cerebrospinal fluid at the time of enrollment.
3. Patients must have ECOG Performance Status 0-3.
4. Patients must have hepatic and renal function within institutional ULN within one week (< 7 days) of protocol entry.
   • Serum Bilirubin
   • Serum Creatinine-Date of test(s)
   • Serum Bilirubin ULN:(usually < 1.2 mg/dL)
   • Serum Creatinine ULN:(usually < 1.3)
     - The levels should be no higher than the upper limit of normal for bilirubin and creatinine prior to each parenteral dose of methotrexate.
5. Patients must not be infected with bacteria or fungi, or must have such an infection under treatment and responding to appropriate antibiotics.
6. Patients must have no other malignancy diagnosed within five years of study entry, except basal cell carcinoma of skin or cervical carcinoma for which successful treatment has been given.
7. Age > 18 years.
8. Women must not be pregnant or breastfeeding because some of the agents used in this study are teratogenic and some are secreted in human milk.
   • All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy.
   • - Woman of childbearing potential?
   • - Date of test
9. Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception.
10. Patients must not be HIV+ or hepatitis B+. Patients must also have no evidence of active CMV infection by molecular detection methods such as DNA capture, PCR, or antigen test prior to beginning alemtuzumab therapy.

For more information about this trial, please contact the Study Coordinator.

Contacts

Michael Craig, MD, Principal Investigator
304-293-4229, craigm@rcbhsc.wvu.edu

Sylvia Mcewuen, Study Coordinator
(304)293-1683, smcewuen@hsc.wvu.edu

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Leukemia

Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders (ECOG 3903)

Objectives

1. To provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients for accrual to ECOG leukemia trials.
2. To obtain baseline materials for correlative studies outlined in parent clinical protocols.

Eligibility

NOTE: All questions regarding eligibility should be directed to the ECOG Coordinating Center at (617) 632-3610.

NOTE: Institutions may use the eligibility checklist as source documentation if it has been reviewed, signed, and dated prior to registration by the treating physician.

1. Patients must be considered for enrollment into one or more ECOG treatment trials for acute or chronic leukemia.
   
   NOTE: The suspected clinical diagnosis or differential diagnoses and the protocol number(s) of the treatment protocol(s) under consideration must be provided to ECOG's Leukemia Translational Studies Laboratory. This will assure that the laboratory utilizes antibody panels and performs functional assays required by any treatment protocol under consideration.
   
   
2. Any ECOG treatment protocol that is being considered for the patient must be active and accruing.
3. Patients must not yet have started treatment on their respective ECOG treatment trial.
4. From patients entered on study by ECOG institutions out of the country, such as Rambam Medical Center in Israel or Instituto de Enfermedades Neoplasicas in Lima, Peru, diagnostic material must be stored under acceptable conditions (as defined by ECOG's reference laboratory) and provided for diagnostic review within 6-9 months of accrual to the clinical protocol.
5. Patients may be entered simultaneously on this laboratory protocol and a chosen treatment protocol if immediate treatment is medically indicated. The requested materials must be submitted prior to start of therapy. If subsequent diagnostic review reveals a misdiagnosis on the part of the referring institution, the patient will be removed from the treatment protocol that was chosen incorrectly.

For more information about this trial, please contact the Study Coordinator.

Contacts

Michael Craig, MD, Principal Investigator
304-293-4229, craigm@rcbhsc.wvu.edu

Sylvia Mcewuen, Study Coordinator
(304)293-1683, smcewuen@hsc.wvu.edu

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Leukemia

A Phase IIB Study of Molecular Responses to Imatinib at Standard or Increased Doses for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. (ECOG S0325)

Objectives

1. To test whether increasing the dose of imatinib (STI571, Gleevec®) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase.
2. To estimate rates of cytogenetic and hematologic responses to each of the two imatinib dose levels.
3. To evaluate in a preliminary manner the prognostic effects of der(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib.
4. To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment.
5. To estimate the frequency and severity of toxicities of the two treatment regimens.

Eligibility

1. Patients must have a diagnosis of CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 14 days before registration. Patients must have confirmation of the Philadelphia chromosome or variants of the (9;22) translocation by cytogenetics or by FISH or be positive for BCR-ABL by RT-PCR. (Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible.)
2. Patients must be registered on this study within 180 days after the date of first cytogenetic or molecular analysis demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation or testing positive for Bcr-Abl by RTPCR.
3. Patients must have reached their 18th birthdays.
4. Patients must have Zubrod performance status 0-2.
5. Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Patients must not have received any prior chemotherapy regimen for peripheral blood stem cell mobilization. (Prior collection of unmobilized peripheral blood stem cells is permitted.)
6. Patients must have a serum bilirubin, and SGOT/AST or SGPT/ALT, all ≤ 2.0 x the institutional upper limit of the normal (IULN). Studies must be performed within 14 days prior to registration.
7. Patients (SWOG institutions only) must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients." Collection of the pretreatment bone marrow specimen must be completed within 14 days prior to registration. The pretreatment bone marrow specimen must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetic analysis as described on protocol SWOG-9007, and an aliquot of the bone marrow (or peripheral blood if the marrow aspiration is a dry tap) must be submitted for FISH analysis. Note that protocol SWOG-9007 also requires submission of bone marrow specimens at the time of progression to the accelerated or blastic phase of CML or the loss of complete hematologic response and every six months while the patient is on this study.
8. Patients (SWOG institutions only) must be registered on S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary." Specimens of peripheral blood and bone marrow must be submitted to the Southwest Oncology Group Lymphoid Leukemia and CML Centralized Laboratory in Seattle, Washington as described in S9910. Collection of pretreatment blood and marrow specimens must be completed within 14 days prior to registration. Note that this study also requires submission of peripheral blood and bone marrow specimens at various times after entry Into the study; Optional enrollment of the patient into the repository function of S9910 is outlined in the informed consent documents.
9. Patients must not have undergone major surgery within 28 days before registration, and must have fully recovered from any other prior major surgery.
10. Patients must not be pregnant or nursing because the study treatment may cause fetal harm when administered to a pregnant woman and excretion in breast milk is unknown. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
11. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.
12. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day. In calculating days of tests and measurements, the day a test or measurement Is done Is considered Day 0. Therefore, If a test is done on a Monday, the Monday two weeks later would be considered Day 14. This allows for efficient patient scheduling without exceeding the guidelines.
13. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
14. At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base.

For more information about this trial, please contact the Study Coordinator.

Contacts

Michael Craig, MD, Principal Investigator
304-293-4229, craigm@rcbhsc.wvu.edu

Sylvia Mcewuen, Study Coordinator
(304)293-1683, smcewuen@hsc.wvu.edu

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Leukemia

A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission after Primary Induction Failure. (ECOG 2902)

Objectives

The purpose of this study is to determine how well the experimental drug called Farnesyl Transferase Inhibitor (FTI) R115777 can keep your cancer in remission and to see what side effects (good or bad) are caused by the drug.

Eligibility

Note: All questions regarding eligibility should be directed to the ECOG Coordinating Center at (617) 632-3610.

1. Patients eligible to enter this study must fall into one of these categories:
   • Patients in first complete remission following primary induction failure
     • Patients must have received at least two chemotherapy induction regimens.
   • Patients in second or subsequent complete remission (CR2)
2. Patients must be in CR by blood counts and bone marrow studies (see section 6.1) to enter the study.
   • Patients who have had an autologous stem cell transplant within 3 months prior to enrollment may be enrolled on study if platelet count is 50,000 - 100,000/mm³ as long as other criteria for CR have been met.
3. Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) that they had AML of one of the following types prior to achievement of CR.
   • Acute myeloblastic leukemia (M0,M1,M2)
   • Acute myelomonocytic leukemia (M4)
   • Acute monocytic leukemia (M5)
   • Acute erythroleukemia (M6)
   • Acute megakaryocytic leukemia (M7)
   • RAEB-T
4. Patients with acute promyelocytic leukemia are not eligible.
5. Patients must be registered within 60 days following documentation of CR following induction therapy or within 60 days of discharge from the hospital following post-remission therapy.
   • Patients who did not have a bone marrow biopsy done to document remission status may be considered to be in CR from the date at which they meet hematologic parameters for CR as long as current bone marrow studies confirm CR. The confirmatory bone marrow aspirate should be done before randomization.
6. Patients who have received consolidation chemotherapy are eligible. Patients must have recovered from the effects of any prior chemotherapy.
7. Patients who have received autologous stem cell transplant are eligible.
8. Patients who have not received any form of post-remission therapy are eligible for study.
9. Patients who have received allogeneic BMT in their current remission are ineligible. Patients who had allogeneic transplant and are currently in remission after subsequent relapse are eligible.
10. Patients with a history of extramedullary disease are eligible if they are, in complete remission at the time of study entry and no longer requiring therapy for their extramedullary disease.
11. Patients must not be pregnant or breast-feeding since the effects of this treatment on the fetus or breast-fed infant is unknown. All females of childbearing potential must have a blood test or urine study < 2 weeks prior to randomization to rule out pregnancy.
12. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
13. Patients must not be known to have an allergy to imidazole drugs, such as clotrimazole ketaconazole, miconazole, econazole, or terconazole, as there may be an increased risk or allergic reaction to R115777. This does not include fluconazole, voriconazole, or itraconazole.
14. Patient must be ≥ 18 years of age.
15. Patients must meet the following criteria at the time of enrollment:
    • ECOG performance status of 0 - 2
    • Patients must not have:
      • Active cardiac or pulmonary disease. But patient will be eligible if disease is medically controlled.
      • Active renal disease. Creatinine must be ≤ 1.5 x upper limit of normal. Laboratory samples must be obtained ≤ 2 weeks prior to randomization.
      • Active hepatic disease. Total direct bilirubin must be < 2 mg/dl and AST and ALT must be ≤ 2.5 times the upper limit of normal. Laboratory samples must be obtained ≤ 2 weeks prior to randomization.
    • ANC > 1000/mm³. Laboratory samples must be obtained ≤ 2 weeks prior to randomization.
    • Platelet count > 100,000/mm³ (50,000/mm³ if prior autologous stem cell transplant). Laboratory samples must be obtained ≤ 2 weeks prior to randomization.
16. Patients must not be taking a hepatic enzyme-inducing anti-convulsant. A patient will not be eligible for the study if the patient is currently taking one of these agents and cannot be switched to a non-hepatic enzyme-inducing anti-convulsant.

For more information about this trial, please contact the Study Coordinator.

Contacts

Michael Craig, MD, Principal Investigator
304-293-4229, craigm@rcbhsc.wvu.edu

Sylvia Mcewuen, Study Coordinator
(304)293-1683, smcewuen@hsc.wvu.edu

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LUNG CANCER

Lung Cancer

A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) (ECOG 5501)

Objectives

To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>4 cm) - IIIA NSCLC.

Eligibility

In order to be eligible for this trial, patients must have undergone complete resection of their
cancer [stage IB (> 4 cm) - IIIA (T2-3N0, T1-3N1, T1-3N2) non-small cell lung cancer
(NSCLC)] prior to enrollment. Accepted types of resection will consist of lobectomy, sleeve
lobectomy, bi-lobectomy or pneumonectomy. Resections by segmentectomy or wedge
resection will not be accepted. Mediastinal lymph node sampling will be expected either at
time of a pre-operative mediastinoscopy, or intraoperatively. Please refer to Section 5 for
resection specifics.        

1. If patient’s tumor is stage IB, it must be > 4 cm in size.
   • Is patient’s tumor stage IB? ______ (Yes or No)
   • If ‘yes’, is tumor > 4 cm? _________ (Yes or No)
2. Patients must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered from surgery. Date of surgery:__________ Planned date of randomization:__________
3. Age > 18 years.
4. ECOG performance status 0 or 1.
5. Patients must not have received the following:
   • Prior systemic chemotherapy at any time.
   • Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now
     considered cured is acceptable.)
6. Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
7. Required laboratory values obtained within two weeks of randomization:
   • ANC ≥ 1500 mm3
   • Platelets ≥ 100,000/mm3
   • Prothrombin time/INR ≤ 1.5
   • Or, if patient is on therapeutic anticoagulation, prothrombin time/INR < 3.0
   • Is patient on therapeutic anticoagulation? _______ (Yes or No)
   • PTT ≤ institutional upper limit of normal (ULN)
   • Total Bilirubin ≤ 1.5 mg/dL
   • SGOT (AST) < 5 x upper limit of normal (ULN):
   • SGPT (ALT) < 5 x upper limit of normal (ULN):
8. Patients must have adequate renal function as determined by the following tests within 2 weeks prior to randomization:
   • Serum Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
   • Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be< 1000 mg for patient enrollment.

NOTE: UPC ratio of spot urine is an estimation of the 24 urine protein excretion – a UPC
ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 g. UPC ratio is
calculated using one of the following formulas:
[urine protein]/[urine creatinine] – if both protein and creatinine are reported in mg/dL
[(urine protein) x 0.088]/[urine creatinine] – if urine creatinine is reported in mmol/L

11. Patients with a history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization.
12. Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial.
13. Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk from bevacizumab. It is also unknown if these agents are excreted into breast milk.

    All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy.

14. Both fertile men and women must agree to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab.
15. Patients must not have ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, psychiatric illness/social situations or any other medical condition that would limit compliance with study requirements.
16. Patients must have no history of bleeding diathesis or coagulopathy.
17. Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy.
18. Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents (NSAIDS) are eligible. Treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed.
19. Patients must not have serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization.
20. Patients must not have a history of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to randomization.
21. Patients must not have any anticipated major surgical procedure(s) during the course of the study.
22. Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
23. Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies meet entry criteria 3.8. Caution must be exercised for patients requiring anticoagulation, including treatment with low dose heparin or low molecular weight heparin for DVT prophylaxis while on study due to an increased risk of bleeding with bevacizumab.
22. Patients with ongoing post-operative hemoptysis (defined as bright red blood of ½ teaspoon or more) are not eligible. Patients with pre-operative hemoptysis that has resolved postoperatively are eligible.

For more information about this trial, please contact the Study Coordinator.

Contacts

John S. RogersII, MD, Principal Investigator
(304) 293-4980, jrogers@hsc.wvu.edu

Dawn Scopel , Study Coordinator
(304)293-7375, dscopel@hsc.wvu.edu

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Melanoma

Phase III Randomized Study of Four Weeks High Dose Alfa-Interferon 2b in Stages T3-T4 or N1 (Microscopic) Melanoma (ECOG 1697)

Objectives

1. The primary objective of this study is to compare the effect of treatment with 4 weeks of high dose Alfa-Interferon 2b on the relapse free survival of patients with resected melanoma in the following categories: (1) T₃N₀(1.5 -4 mm), (2) T₄N₀ (greater than 4 mm), (3) T_1-4N₁ (microscopic, onelymph node positive).
2. The secondary objective is to compare the effect of high dose Alfa-Interferon 2b on overall survival of patients with resected melanoma in the following categories: (1) T3N0(1.5 -4 mm), (2) T4N0 (greater than 4 mm), (3) T1-4N1 (microscopic, one lymph node positive).
3. To assess the toxicity of high dose Alfa-Interferon 2b.
4. To compare the two treatment arms (Arm A: Observation; Arm B: High Dose Alfa-Interferon 2b) with respect to quality-adjusted survival.

Eligibility

1. Only patients with melanoma of a cutaneous origin are eligible for this study.
2. Only patients with initial presentation of primary melanoma are eligible.Patients must not have clinically palpable lymphadenopathy. If patients undergo pathologic staging of the regional lymph node basin either as part of a sentinel node. evaluation procedure or elective lymphadenectomy and have positive nodes, only those with microscopic involvement in one sentinel or other lymph node will be allowed on study. If no regional lymph node basin pathologic staging is done and lymph nodes are not clinically positive, patients will also be allowed on study. Patients with a positive sentinel node should undergo complete lymphadenectomy of the nodal basin
3. Patients must fulfill one of the following criteria:
   • T₃N₀M₀ - Primary melanoma of 1.5 - 4 mm Breslow depth, clinically negative regional lymph nodes, pathologic status unknown.
   • T₃N₀M₀ - Primary melanoma of 1.5 - 4 mm Breslow depth, histologically negative regional lymph nodes.
   • T₄N₀M₀ - Primary melanoma greater than 4 mm Breslow depth..
   • T_1-4N₁ - Primary melanoma, one lymph node positive microscopically.
4. Patients must complete all primary therapy (wide excision with orwithout lymphadenedomy) and be randomized within 70 days of their wide excision, and no longer than 84 days after initial biopsy.
5. Patients must have undergone an adequate wide excision of the primary lesion.
6. Patients must have no other current malignancies. Patients with prior history of in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark 1 melanoma in situ or basal or squamous skin cancer are eligible. Patients with other malignancies are eligible if they have been continuously disease free for 5 years priorto the time of randomization. Patients with any other history of invasive melanoma are not eligible.
7. Patients must have no clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease.
8. Patients must not have autoimmune disorders, conditions of immunosuppression, or be currently on treatment with systemic corticosteroids, including: oral steroids (Le., prednisone, dexamethasome), topical steroid creams or ointments, or any steroid containing inhalers.
9. Patients must not have a history of active ischemic heart disease or cerebro-vascular disease or congestive .heart failure (NYHA class > 2).
10. Patients must not have had prior radiotherapy, chemotherapy, including infusion or perfusion therapy, or any immunotherapy including tumorvaccines, interferon, interleukins, levamisole or other biologic response modifiers for their melanoma.
11. Patients must not have clinically palpable lymphadenopathy.
12. Patients must be 18 years of age or older.
13. Women of childbearing potential must not be pregnant (negative serum bHCG within 2 weeks of randomization) or lactating. The effects of Interferon treatments on an unborn fetus are unknown.
14. Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 6 months after completing or discontinuing treatment.
15. Patients must have ECOG performance status 0-1 within 8 weeks of randomization.
16. Patients must have WBC greater than or equal to 3,000/mm3, platelet count greater than or equal to 125,000/mm3, and hematocrit greater than or equal to 30% obtained within 8 weeks of randomization.
17. Patients must have AST, LDH, alkaline phosphatese and bilirubin less than or equal to 2 x institutional upper limit (IUL) of normal and serum creatinine less than or equal to 1.8 mg/dl or BUN less than or equal to 33 mg/dl-all obtained within 8 weeks of randomization. If LDH or alkaline phosphatase are above normal, a contrast-enhanced CT scan or MRI of liver is required to document the absence of tumor prior to randomization. This scan must be performed between initial biopsy of melanoma and randomization.
18. Patients must have a CXR or chest CT and, if clinically indicated, a CT scan or MRI of the head performed between initial biopsy of melanoma and randomization.
19. Patients must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude full participation in the protocol.
20. Patients must not be entered who have another significant medical or surgical condition, or who require any medication or treatment regimen which may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study drug.

For more information about this trial, please contact the Study Coordinator.

Contacts

Miklos L. Auber , MD, Principal Investigator
(304) 293-4229, mauber@hsc.wvu.edu

Dawn Scopel , Study Coordinator
(304)293-7375, dscopel@hsc.wvu.edu

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Other Studies

Phase II Trial of BAY 43-9006 in Patients with Advanced Anaplastic Carcinoma of the Thyroid (NCI 7037/CASE 5304)

Objectives

1. To determine that the objective response rate of BAY 43-9006 given to patients with anaplastic carcinoma of the thyroid is 20% or greater. (Patients recruited to the study will also be followed for survival. )
2.  To further characterize the safety profile of BAY 43-9006 when given to  patients with advanced anaplastic carcinoma of the thyroid.

Eligibility

1. Patients with anaplastic thyroid cancer are eligible if their disease has progressed after treatment with cytotoxic chemotherapy (given alone or with radiation) and their disease is not considered amenable to radiation or surgery with curative intent.
2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan or evaluable disease. See section 9.0 for the evaluation of disease. Measurable disease should not be in a previously irradiated field.
3. Patients may have received up to 2 prior systemic cytotoxic chemotherapy regimens. Patients who have not received any prior systemic cytotoxic chemotherapy regimens are eligible. Any combined modality systemic cytoxic chemotherapy will be considered one prior cytotoxic regimen.

Note: Given the natural history of anaplastic thyroid cancer, the disease is considered systemic at time of diagnosis even in the absence of overt clinical metastases. In many instances patients may in fact have received combined modality therapy with surgery or radiation + chemotherapy (e.g., radiosensitizing chemotherapy such as low-dose, weekly doxorubicin even in the setting of metastatic disease).

4. For patients relapsing following initial surgery or radiotherapy + chemotherapy, they must have fully recovered from side effects of treatment i.e. if patients meet all eligibility criteria, they will be able to start treatment as early as 7 days after prior therapy. This is to accommodate the aggressive natural history of the disease.
5. Age >18 years. Because no dosing or adverse event data are currently available on the use of BAY 43-9006 in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase II trials.
6. Life expectancy of greater than 8 weeks.
7. ECOG performance status 0-2 (Karnofsky >50%; see Appendix A). Patients who are ECOG performance status 2 must not have symptomatic bulky disease that impairs the airway or impedes swallowing.
8. Patients must have normal organ and marrow function as defined below:

- absolute neutrophil count >1,250/μL
- platelets >100,000/μL
- total bilirubin < 1.5 X upper limit of normal
- AST(SGOT)/ALT(SGPT) <3.5 X institutional upper limit of normal
- creatinine < 1.5 X upper limit of normal
- PTT < 1.5 X upper limit of normal
- INR < 2.0

9. Patients must be able to swallow an oral medication.
10. The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because raf kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
11. Ability to understand and the willingness to sign a written informed consent document.

For more information about this trial, please contact the Study Coordinator.

Contacts
Scot Remick, MD, Principal Investigator
304-293-0781, sremick@hsc.wvu.edu

Sylvia Mcewuen, Study Coordinator
(304) 293-1683, smcewuen@hsc.wvu.edu

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Other Studies

A Phase II Randomized Trial of BAY 43-9006, a Novel Raf Kinase Inhibitor, versus BAY 43-9006 plus Paclitaxel/Carboplatin in Women with Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer (NCI 6557/CASE 2804)

Objectives

1. To conduct two parallel phase II trials: 1) single agent BAY 43-9006 and 2) BAY 43-9006 plus carboplatin and paclitaxel

2. To compare the progression-free survival rate of single agent BAY 43-9006 to that of the combination of BAY 43-9006 plus carboplatin and paclitaxel.

Eligibility

1. Patients with recurrent epithelial ovarian cancer, primary peritoneal or fallopian tube cancer that is considered platinum sensitive (a treatment free interval greater than 6 months) will be eligible for this trial.

2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease. Measurable disease should not be in a previously irradiated field.

3. Patients must have received prior therapy with a platinum-based regimen before study enrollment but patients must not have had more than 2 chemotherapy regimens, and must be platinum sensitive (a treatment interval of greater than 6 months). Prior hormonal therapy is allowed.

4. Age >18 years. Because no dosing or adverse event data are currently available on the use of BAY 43-9006 in combination with paclitaxel and carboplatin in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.

5. Life expectancy of greater than 12 weeks.

6. ECOG performance status 0-2 (Karnofsky >80%; see Appendix A).

7. Patients must have normal organ and marrow function as defined below:

• hemoglobin >9 gm/dL
• absolute neutrophil count >1,500/L
• platelets >100,000/L
• total bilirubin < 1.5 X upper limit of normal
• AST(SGOT)/ALT(SGPT) <2 X institutional upper limit of normal
• creatinine < 2.0 mg/dL

8. The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because raf kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

9. Patients must have adequate intestinal function i.e. does not require IV hydration or nutritional support.

10. Ability to understand and the willingness to sign a written informed consent document.

For more information about this trial, please contact the Study Coordinator.

Contacts

Scot Remick, MD, Principal Investigator
304-293-0781, sremick@hsc.wvu.edu

Shannon Filburn, Study Coordinator
(304)293-2745, sfilburn@hsc.wvu.edu

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Other Studies

A Multicenter, Open-Label, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Combretastatin A-4 Phosphate in Combination with Paclitaxel and Carboplatin in Comparison with Paclitaxel and Carboplatin Against Anaplastic Thyroid Carcinoma (OXC4T4)

Objectives

• To compare the antineoplastic efficacy of CA4P + paclitaxel + carboplatin+ with paclitaxel + carboplatin against ATC by measuring overall survival

• To evaluate the safety and tolerability of the triple combination of CA4P + paclitaxel + carboplatin
• To assess specified objective events: tracheostomies, PEG tube placements, and weight loss

Eligibility

1. Patients must have anaplastic thyroid carcinoma histologically or cytologically confirmed by a pathology review.
2. Patients may have been refractory to or progressed during or after therapy, or relapsed within 6 months following initial combined modality therapy (usually including systemic chemotherapy and radiation) for regionally advanced disease.
3. Where patients have received combined modality therapy for metastatic disease, systemic therapy is limited to one chemotherapy regimen that is clearly administered contiguously, (i.e., in an uninterrupted primary therapeutic approach). Patients who receive chemotherapy for metastatic disease after a combined modality approach are ineligible.
4. In p