Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
- Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ
cell tumors treated with intensive induction chemotherapy comprising cisplatin,
vincristine, bleomycin, and carboplatin followed by bleomycin, etoposide phosphate, and
cisplatin (BEP) vs standard BEP chemotherapy.
- Compare overall and progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified
according to participating center, pre-protocol low-dose chemotherapy (yes vs no), and other
clinically important factors. Patients are randomized to 1 of 2 treatment arms.
- Arm I (BEP): Patients receive bleomycin IV over 15 minutes once on day 1 or 2 and days
8 and 15 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days
1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II (CBOP/BEP): Patients receive chemotherapy according to the following schedule:
- Weeks 1-6: Patients receive cisplatin IV over 6 hours on days 1, 2, 8, 15, 16, and
22 (OR over 4 hours on days 1-5 and 15-19); vincristine IV on days 1, 8, 15, 22,
29, and 36; bleomycin IV over 15 minutes on days 1, 15, 29, and 36 and bleomycin
IV continuously on days 8-12 and 22-25; and carboplatin IV over 30-60 minutes on
days 8 and 22.
- Weeks 7-15: Patients receive bleomycin IV continuously on days 1-5, 8-12, and
15-19 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days
1-5. Treatment repeats every 21 days for 4 courses.
After completion of study treatment, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rates to treatment
Robert A. Huddart, MD
Royal Marsden NHS Foundation Trust