Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT00182702
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2005-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 13850A | None | None | View | |
| N01CM62201 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62209 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000440071 | REGISTRY | PDQ (Physician Data Query) | View |