Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
- Determine the feasibility of accelerated treatment comprising bleomycin, etoposide,
cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
- Determine the toxicity of this regimen (particularly with respect to renal, pulmonary,
and neurological function) in these patients.
- Determine the response rate in patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, pilot study.
Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV
over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day
4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Treatment
Michael Williams, MD
Cambridge University Hospitals NHS Foundation Trust