Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
- Conditions
- Extragonadal Germ Cell TumorTesticular Germ Cell TumorTeratoma
- Registration Number
- NCT00301782
- Lead Sponsor
- Medical Research Council
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, 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 combination chemotherapy regimen is more effective in treating germ cell tumors.
PURPOSE: This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating male patients with germ cell tumors.
- Detailed Description
OBJECTIVES:
Primary
* Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ cell tumors treated with intensive induction chemotherapy comprising cisplatin, vincristine, bleomycin, and carboplatin followed by bleomycin, etoposide phosphate, and cisplatin (BEP) vs standard BEP chemotherapy.
Secondary
* Compare overall and progression-free survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to participating center, pre-protocol low-dose chemotherapy (yes vs no), and other clinically important factors. Patients are randomized to 1 of 2 treatment arms.
* Arm I (BEP): Patients receive bleomycin IV over 15 minutes once on day 1 or 2 and days 8 and 15 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days 1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
* Arm II (CBOP/BEP): Patients receive chemotherapy according to the following schedule:
* Weeks 1-6: Patients receive cisplatin IV over 6 hours on days 1, 2, 8, 15, 16, and 22 (OR over 4 hours on days 1-5 and 15-19); vincristine IV on days 1, 8, 15, 22, 29, and 36; bleomycin IV over 15 minutes on days 1, 15, 29, and 36 and bleomycin IV continuously on days 8-12 and 22-25; and carboplatin IV over 30-60 minutes on days 8 and 22.
* Weeks 7-15: Patients receive bleomycin IV continuously on days 1-5, 8-12, and 15-19 and etoposide phosphate IV over 1 hour and cisplatin IV over 4 hours on days 1-5. Treatment repeats every 21 days for 4 courses.
After completion of study treatment, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rates to treatment
- Secondary Outcome Measures
Name Time Method Overall survival Progression-free survival Toxicity
Trial Locations
- Locations (20)
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
University College of London Hospitals
🇬🇧London, England, United Kingdom