Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003643
Status:
UNKNOWN
Last Update Posted:
2012-03-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Men With Germ Cell Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase IIIII Study of TaxolPaclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer
PURPOSE This randomized phase IIIII trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer
PURPOSE This randomized phase IIIII trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer
Detailed Description:
OBJECTIVES
Phase II
Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin cisplatin and etoposide BEP vs bleomycin cisplatin etoposide and paclitaxel T-BEP
Define the toxicity profile of T-BEP in these patients
Phase III
Compare the disease-free survival of patients treated with these regimens
Compare the complete response rates and overall survival of patients treated with these regimens
Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens
Compare the acute and intermediate 1-2 years side effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to histology seminoma vs non-seminoma and hospital Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1 8 and 15
Arm II Patients receive cisplatin etoposide and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1 Patients also receive filgrastim G-CSF subcutaneously on days 6-15
In both arms treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 84-164 patients 42-82 per treatment arm will be accrued for the phase II study A total of 498 patients 249 per treatment arm will be accrued for the phase III study Accrual will be completed within 4 years
Phase II
Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin cisplatin and etoposide BEP vs bleomycin cisplatin etoposide and paclitaxel T-BEP
Define the toxicity profile of T-BEP in these patients
Phase III
Compare the disease-free survival of patients treated with these regimens
Compare the complete response rates and overall survival of patients treated with these regimens
Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens
Compare the acute and intermediate 1-2 years side effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to histology seminoma vs non-seminoma and hospital Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1 8 and 15
Arm II Patients receive cisplatin etoposide and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1 Patients also receive filgrastim G-CSF subcutaneously on days 6-15
In both arms treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 84-164 patients 42-82 per treatment arm will be accrued for the phase II study A total of 498 patients 249 per treatment arm will be accrued for the phase III study Accrual will be completed within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-30983 | None | None | None |