Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021099
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-07-11
Brief Title:
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Epothilone B Analogue BMS-247550 NSC 710428 q21 Days In Advanced Carcinoma Of The Urothelium
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:
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone
II Assess the toxicity of this drug in these patients
OUTLINE Patients are stratified according to prior treatment with taxanes yes vs no
Patients receive ixabepilone IV over 3 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
I Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone
II Assess the toxicity of this drug in these patients
OUTLINE Patients are stratified according to prior treatment with taxanes yes vs no
Patients receive ixabepilone IV over 3 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
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 |
|---|---|---|---|
| CDR0000068747 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E3800 | None | None | None |
| U10CA021115 | NIH | None | None |