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Sponsored by: |
Queen Mary University of London |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324298 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Testicular Germ Cell Tumor |
Drug: bleomycin Drug: cisplatin Drug: etoposide Procedure: management of therapy complications |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Estimated Enrollment: | 210 |
Study Start Date: | July 2003 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of metastatic germ cell cancer of the testes
PATIENT CHARACTERISTICS:
No impaired respiratory function, including any of the following:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Michael Williams, MD 44-122-321-7020 michael.williams@addenbrookes.nhs.uk | |
Basildon University Hospital | Recruiting |
Basildon, England, United Kingdom, SS16 5NL | |
Contact: Steve Nicholson 44-1268-593-227 wondersn@doctors.org.uk | |
Essex County Hospital | Recruiting |
Colchester, England, United Kingdom, C03 3NB | |
Contact: B. Sizer, MD 44-1206-747474 | |
Ipswich Hospital | Recruiting |
Ipswich, England, United Kingdom, IP4 5PD | |
Contact: Christopher Scrase, MD 44-147-370-4177 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: John Chester 44-113-243-3144 | |
University College of London Hospitals | Recruiting |
London, England, United Kingdom, WIT 3AA | |
Contact: Stephen J. Harland, MD 44-20-7380-9041 stephen.harland@uclh.org | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Robert A. Huddart, MD 44-20-8661-3457 robert.huddart@icr.ac.uk | |
Saint Bartholomew's Hospital | Recruiting |
London, England, United Kingdom, EC1A 7BE | |
Contact: Jonathan Shamash, MD, FRCP 44-207-601-7221 jonathan.shamash@bartsandthelondon.nhs.uk | |
Southend University Hospital NHS Foundation Trust | Recruiting |
Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
Contact: Steve Nicholson 44-1702-435-555 ext. 4148 wondersn@doctors.org.uk | |
Norfolk and Norwich University Hospital | Recruiting |
Norwich, England, United Kingdom, NR4 7UY | |
Contact: M. J. Ostrowski 44-603-286-286 |
Study Chair: | Jonathan Shamash, MD, FRCP | St. Bartholomew's Hospital |
Study ID Numbers: | CDR0000472976, BARTS-TE3, EU-20608, ISRCTN08648791 |
Study First Received: | May 10, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00324298 |
Health Authority: | Unspecified |
drug/agent toxicity by tissue/organ stage III malignant testicular germ cell tumor |
Cisplatin Neoplasms, Germ Cell and Embryonal Testicular cancer Testicular Neoplasms |
Bleomycin Etoposide phosphate Etoposide Malignant germ cell tumor |
Neoplasms Neoplasms by Histologic Type Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic Pharmacologic Actions |