Trial Information

A Randomized Phase III Toxicity Study of Day 2, 3, 8, 15 Short (30 Minute) Versus Day 1, 2, 3 Long (72 Hours) Infusion Bleomycin for Patients With IGCCCG Good Prognosis Germ Cell Tumors, TE3

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.