Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070096
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2003-10-03
Brief Title:
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTICDIAGNOSTIC PROTOCOL
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as ixabepilone work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin
PURPOSE This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin
Detailed Description:
OBJECTIVES
Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors
Determine the safety of this drug in these patients
OUTLINE Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 13-4 years
Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors
Determine the safety of this drug in these patients
OUTLINE Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study within 13-4 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 |
|---|---|---|---|
| NCI-6022 | None | None | None |
| MSKCC-03041 | None | None | None |