Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

UNICANCER263 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

263

Conditions

Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor

Interventions

bleomycin sulfateBIOLOGICAL

At least one course administered

cisplatinDRUG

At least one course administered

etoposideDRUG

At least one course administered

ifosfamide

Eligibility

Sex: ALLMin age: 16 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (24)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Outcomes

Primary Outcomes

Progression-free Survival Rate After 1 Course of Treatment

Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.

Time frame: 3 years from randomization

Secondary Outcomes

Overall Survival

To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.

Time frame: 3 years from randomization

Data from ClinicalTrials.gov

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