Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles
Condition: Drug/Agent Toxicity by Tissue/Organ; Testicular Germ Cell Tumor
MeSH terms: Neoplasms, Germ Cell and Embryonal; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): bleomycin sulfate; cisplatin; etoposide; management of therapy complications
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Etoposide; Bleomycin
Allocation: Randomized
Primary purpose: Treatment
Keywords: drug/agent toxicity by tissue/organ; stage III malignant testicular germ cell tumor