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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Drug/Agent Toxicity by Tissue/Organ
- Sponsor
- Queen Mary University of London
- Enrollment
- 210
- Locations
- 10
- Primary Endpoint
- Pulmonary toxicity
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of bleomycin is more effective when given together with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.
PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with etoposide and cisplatin in treating patients with metastatic germ cell cancer of the testicles.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pulmonary toxicity
Secondary Outcomes
- Progression-free survival
- Overall survival
- Response to treatment