Clinical Trials Directory

Trials / Completed

CompletedNCT01168232

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
42 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGIxabepiloneGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2010-09-07
Primary completion
2013-11-26
Completion
2013-11-26
First posted
2010-07-23
Last updated
2019-08-08
Results posted
2017-01-23

Locations

78 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01168232. Inclusion in this directory is not an endorsement.