Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 11:45 AM
Study NCT ID:
NCT01168232
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2010-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Status:
COMPLETED
Status Verified Date:
2019-08
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 the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.
II. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.
II. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival.
OUTLINE:
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
I. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.
II. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.
II. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival.
OUTLINE:
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-02056 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| GOG-0130F | None | None | View | |
| CDR0000681684 | None | None | View | |
| GOG-0130F | OTHER | NRG Oncology | View | |
| GOG-0130F | OTHER | CTEP | View | |
| U10CA180868 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA027469 | NIH | None | https://reporter.nih.gov/quic… | View |