Trial Information

Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer

OBJECTIVES:

Phase II

- Compare the complete response rates in men with intermediate prognosis germ cell cancer
treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin,
etoposide, and paclitaxel (T-BEP).

- Define the toxicity profile of T-BEP in these patients.

Phase III

- Compare the disease-free survival of patients treated with these regimens.

- Compare the complete response rates and overall survival of patients treated with these
regimens.

- Compare symptoms and aspects of quality of life at baseline and after treatment in
patients treated with these regimens.

- Compare the acute and intermediate (1-2 years) side effects of these regimens in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on
days 1, 8, and 15.

- Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel
IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on
days 6-15.

In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of
disease progression or unacceptable toxicity.

Quality of life is assessed before treatment randomization and at 1 and 2 years after
randomization.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for
the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the
phase III study. Accrual will be completed within 4 years.