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Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Testicular Germ Cell Tumor

Intervention: bleomycin sulfate (Biological); cisplatin (Drug); etoposide (Drug); management of therapy complications (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Queen Mary University of London

Official(s) and/or principal investigator(s):
Jonathan Shamash, MD, FRCP, Study Chair, Affiliation: St. Bartholomew's Hospital

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Primary Purpose: Treatment

Primary outcome: Pulmonary toxicity

Secondary outcome:

Response to treatment

Progression-free survival

Overall survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of metastatic germ cell cancer of the testes

- Good-prognosis disease

- Eligible for treatment with bleomycin, etoposide, and cisplatin

PATIENT CHARACTERISTICS:

- Creatinine clearance ≥ 60 mL/min

- No other prior or concurrent malignancy except basal cell skin cancer

- No other major systemic illness

- No impaired respiratory function, including any of the following:

- Shortness of breath on minimal exertion

- Hypoxia at rest

- Carbon monoxide transfer, total lung capacity, and FEV_1 > 60% of predicted

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

Locations and Contacts

Basildon University Hospital, Basildon, England SS16 5NL, United Kingdom

Addenbrooke's Hospital, Cambridge, England CB2 2QQ, United Kingdom

Essex County Hospital, Colchester, England C03 3NB, United Kingdom

Ipswich Hospital, Ipswich, England IP4 5PD, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England LS9 7TF, United Kingdom

Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom

University College of London Hospitals, London, England WIT 3AA, United Kingdom

Norfolk and Norwich University Hospital, Norwich, England NR4 7UY, United Kingdom

Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom

Southend University Hospital NHS Foundation Trust, Westcliff-On-Sea, England SS0 0RY, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2003
Last updated: August 9, 2013

Page last updated: August 20, 2015

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