Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072215
Status:
TERMINATED
Last Update Posted:
2016-07-04
First Post:
2003-11-04
Brief Title:
Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Study of Paclitaxel Ifosfamide and Cisplatin Versus Vinblastine Ifosfamide and Cisplatin as Second-Line Therapy for Patients With RelapsedResistant Germ Cell Tumors
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 ifosfamide cisplatin paclitaxel and vinblastine work in different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors
PURPOSE This randomized phase III trial is studying paclitaxel ifosfamide and cisplatin to see how well they work compared to vinblastine ifosfamide and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors
PURPOSE This randomized phase III trial is studying paclitaxel ifosfamide and cisplatin to see how well they work compared to vinblastine ifosfamide and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of men with progressive or recurrent metastatic germ cell tumors treated with paclitaxel ifosfamide and cisplatin vs vinblastine ifosfamide and cisplatin as second-line therapy
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the toxicity profiles of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior complete response or partial response with negative markers for at least 6 months yes vs no and relapse at least 2 years after completing first-line chemotherapy for germ cell tumors yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 2-5 Patients also receive filgrastim G-CSF subcutaneously SC on days 7-18 OR pegfilgrastim SC once within 24-72 hours after completion of chemotherapy
Arm II Patients receive vinblastine IV on days 1 and 2 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 1-5 Patients also receive G-CSF SC on days 7-18 OR pegfilgrastim as in arm I
In both arms treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
Primary
Compare the overall survival of men with progressive or recurrent metastatic germ cell tumors treated with paclitaxel ifosfamide and cisplatin vs vinblastine ifosfamide and cisplatin as second-line therapy
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the toxicity profiles of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to prior complete response or partial response with negative markers for at least 6 months yes vs no and relapse at least 2 years after completing first-line chemotherapy for germ cell tumors yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 2-5 Patients also receive filgrastim G-CSF subcutaneously SC on days 7-18 OR pegfilgrastim SC once within 24-72 hours after completion of chemotherapy
Arm II Patients receive vinblastine IV on days 1 and 2 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 1-5 Patients also receive G-CSF SC on days 7-18 OR pegfilgrastim as in arm I
In both arms treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 2 years every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CDR0000339340 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |