Clinical Trial: Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

PRIMARY OBJECTIVES:

I. To determine the response rate of patients with persistent or recurrent carcinosarcoma of the uterus treated with ixabepilone.

II. To determine the nature and degree of toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival of patients treated with this regimen.

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 with response, progression-free survival, and overall survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples from prior surgery may be collected for class III beta-tubulin analysis by IHC.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Objective Tumor Response [ Time Frame: Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days ]
    Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
  • Adverse Events (Grade 3 or Higher) During Treatment Period. [ Time Frame: During treatment and up to 30 days after stopping the study treatment ]
    Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0


Original Primary Outcome:

  • Objective tumor response
  • Frequency and severity of adverse events


Current Secondary Outcome:

  • Progression-free Survival [ Time Frame: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. ]
    Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1
  • Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years of follow-up. ]
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.


Original Secondary Outcome:

  • Progression-free survival
  • Overall survival


Information By: National Cancer Institute (NCI)

Dates:
Date Received: July 22, 2010
Date Started: September 2010
Date Completion:
Last Updated: November 28, 2016
Last Verified: November 2016