Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182702
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2005-09-15
Brief Title:
Ixabepilone in Treating Patients With Metastatic Recurrent or Unresectable Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of BMS 247550 Ixabepilone in Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying how well ixabepilone works in treating patients with metastatic recurrent or unresectable kidney cancer Drugs used in chemotherapy such as ixabepilone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with metastatic recurrent or unresectable renal cell carcinoma treated with ixabepilone
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival rates in patients treated with this drug
II Determine the toxicity of this drug in these patients III Correlate VHL gene mutations with response in patients treated with this drug
IV Correlate VHL pathway protein expression with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 9 weeks until disease progression and then every 3 months for up to 2 years
I Determine the objective response rate in patients with metastatic recurrent or unresectable renal cell carcinoma treated with ixabepilone
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival rates in patients treated with this drug
II Determine the toxicity of this drug in these patients III Correlate VHL gene mutations with response in patients treated with this drug
IV Correlate VHL pathway protein expression with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive ixabepilone IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 9 weeks until disease progression and then every 3 months for up to 2 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 |
|---|---|---|---|
| 13850A | None | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62209 | NIH | None | None |
| CDR0000440071 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62209 |