Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles
NCT ID: NCT00324298
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
210 participants
INTERVENTIONAL
2003-07-31
2011-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
cisplatin
etoposide
management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
50 Years
MALE
No
Sponsors
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Queen Mary University of London
OTHER
Principal Investigators
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Jonathan Shamash, MD, FRCP
Role: STUDY_CHAIR
St. Bartholomew's Hospital
Locations
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Basildon University Hospital
Basildon, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Countries
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Other Identifiers
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CDR0000472976
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20608
Identifier Type: -
Identifier Source: secondary_id
ISRCTN08648791
Identifier Type: -
Identifier Source: secondary_id
BARTS-TE3
Identifier Type: -
Identifier Source: org_study_id