Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301782
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2006-03-09
Brief Title:
Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of Intensive Induction Chemotherapy CBOPBEP and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 CBOPBEP 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
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 CBOPBEP 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2004-000405-22 | None | None | None |
| MRC-TE23 | None | None | None |
| EU-205107 | None | None | None |
| ISRCTN53643604 | None | None | None |