Status:
COMPLETED
Bleomycin, Etoposide, and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles
Lead Sponsor:
Queen Mary University of London
Conditions:
Drug/Agent Toxicity by Tissue/Organ
Testicular Germ Cell Tumor
Eligibility:
MALE
18-50 years
Phase:
PHASE3
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 divid...
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 co...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00324298
Start Date
July 1 2003
End Date
March 1 2011
Last Update
August 12 2013
Active Locations (10)
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1
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
2
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
3
Essex County Hospital
Colchester, England, United Kingdom, C03 3NB
4
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD