Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles

OBJECTIVES:

Primary

• Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin, etoposide, and cisplatin for good-prognosis, metastatic germ cell cancer of the testes.
• Determine if early lung function tests are a predictor for late toxicity.
• Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation.
• Validate the O'Sullivan et al prognostic scoring system for bleomycin toxicity.

Secondary

• Determine response to treatment.
• Determine progression-free survival and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≤ 30 years vs > 30 years), current smoker or has smoked within the past 1 year (yes vs no), and creatinine clearance (≤ 80 mL/min vs > 80 mL/min). Patients are randomized to 1 of 2 treatment arms.

• Arm I (short-infusion schedule of bleomycin): Patients receive etoposide IV over 2 hours on days 1-3, cisplatin IV over 4 hours on days 1 and 2, and bleomycin IV over 30 minutes on days 2, 8, and 15.
• Arm II (long-infusion schedule of bleomycin): Patients receive etoposide and cisplatin as in arm I. Patients also receive bleomycin IV continuously over 72 hours on days 1-3.

In both arms, treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months for 24 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic germ cell cancer of the testes

• Good-prognosis disease
• Eligible for treatment with bleomycin, etoposide, and cisplatin

PATIENT CHARACTERISTICS:

• Creatinine clearance ≥ 60 mL/min
• No other prior or concurrent malignancy except basal cell skin cancer
• No other major systemic illness
• No impaired respiratory function, including any of the following:

• Shortness of breath on minimal exertion
• Hypoxia at rest
• Carbon monoxide transfer, total lung capacity, and FEV_1 > 60% of predicted

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy