Expired Study
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Houston, Texas 77030


Purpose:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.


Study summary:

OBJECTIVES: - Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy. - Compare overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms. - Arm I: Patients receive 3 additional courses of BEP. - Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria: - Histologically confirmed NSGCT - Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels - Clinical stage II-III disease (disseminated disease) - Testicular, retroperitoneal, or mediastinal primary site - Poor prognosis disease, meeting 1 of the following criteria: - Mediastinal primary site - Non-pulmonary visceral metastases - One of the following lab values: - HCG > 50,000 UI/L - AFP > 10,000 ng/mL - Lactate dehydrogenase > 10 times upper limit of normal (ULN) PATIENT CHARACTERISTICS: Age - Over 16 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Absolute granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ 1.5 times ULN Renal - Creatinine clearance > 60 mL/min Other - No other prior malignancy except basal cell skin cancer - No HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00104676


Primary Contact:

Karim Fizazi, MD, PhD
Institut Gustave Roussy


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Clinical Trials Office - M. D. Anderson Cancer Center at the U
Phone: 713-792-3245

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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