Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
|ClinicalTrials.gov Identifier: NCT00301782|
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor||Biological: bleomycin sulfate Drug: carboplatin Drug: cisplatin Drug: etoposide phosphate Drug: vincristine sulfate||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors|
|Study Start Date :||June 2005|
|Actual Study Completion Date :||June 2010|
- Response rates to treatment
- Overall survival
- Progression-free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301782
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2TH|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Gloucestershire Oncology Centre at Cheltenham General Hospital|
|Cheltenham, England, United Kingdom, GL53 7AN|
|Coventry, England, United Kingdom, CV2 2DX|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|Nottingham City Hospital|
|Nottingham, England, United Kingdom, NG5 1PB|
|Rosemere Cancer Centre at Royal Preston Hospital|
|Preston, England, United Kingdom, PR2 9HT|
|Berkshire Cancer Centre at Royal Berkshire Hospital|
|Reading, England, United Kingdom, RG1 5AN|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Inverness, Scotland, United Kingdom, 1V2 3UJ|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Study Chair:||Robert A. Huddart, MD||Royal Marsden NHS Foundation Trust|