Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324298
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2006-05-10
Brief Title:
Bleomycin Etoposide and Cisplatin in Treating Patients With Metastatic Germ Cell Cancer of the Testicles
Sponsor:
Queen Mary University of London
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-01
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 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
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
Detailed Description:
OBJECTIVES
Primary
Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin etoposide and cisplatin for good-prognosis metastatic germ cell cancer of the testes
Determine if early lung function tests are a predictor for late toxicity
Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation
Validate the OSullivan et al prognostic scoring system for bleomycin toxicity
Secondary
Determine response to treatment
Determine progression-free survival and overall survival of patients treated with these regimens
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 mLmin vs 80 mLmin Patients are randomized to 1 of 2 treatment arms
Arm I short-infusion schedule of bleomycin Patients receive etoposide IV over 2 hours on days 1-3 cisplatin IV over 4 hours on days 1 and 2 and bleomycin IV over 30 minutes on days 2 8 and 15
Arm II long-infusion schedule of bleomycin Patients receive etoposide and cisplatin as in arm I Patients also receive bleomycin IV continuously over 72 hours on days 1-3
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
Primary
Determine if long-infusion schedule of bleomycin is less toxic to the lungs than short-infusion schedule of bleomycin in patients who are undergoing combination chemotherapy comprising bleomycin etoposide and cisplatin for good-prognosis metastatic germ cell cancer of the testes
Determine if early lung function tests are a predictor for late toxicity
Determine if any indication of enhanced response to the long-infusion schedule justifies a large-scale phase III evaluation
Validate the OSullivan et al prognostic scoring system for bleomycin toxicity
Secondary
Determine response to treatment
Determine progression-free survival and overall survival of patients treated with these regimens
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 mLmin vs 80 mLmin Patients are randomized to 1 of 2 treatment arms
Arm I short-infusion schedule of bleomycin Patients receive etoposide IV over 2 hours on days 1-3 cisplatin IV over 4 hours on days 1 and 2 and bleomycin IV over 30 minutes on days 2 8 and 15
Arm II long-infusion schedule of bleomycin Patients receive etoposide and cisplatin as in arm I Patients also receive bleomycin IV continuously over 72 hours on days 1-3
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
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 |
|---|---|---|---|
| ISRCTN08648791 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000472976 | REGISTRY | None | None |
| EU-20608 | None | None | None |