Clinical Trial: Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy

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 Leiomyosarcoma of the Uterus

Brief Summary: This phase II trial is studying the side effects and how well ixabepilone works in treating patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with chemotherapy. 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 Summary:

PRIMARY OBJECTIVES:

I. To determine the response rate (complete and partial responses by RECIST 1.1) of ixabepilone in patients with recurrent or persistent leiomyosarcoma of the uterus who have failed one previous chemotherapy regimen.

II. To determine the nature and degree of toxicity of ixabepilone as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 in this cohort of patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival (PFS) and overall survival (OS).

II. To determine the level of beta-III tubulin expression measured by IHC in women with leiomyosarcoma.

III. To determine if beta-III tubulin expression as measured by IHC predicts response to ixabepilone in women with leiomyosarcoma.

OUTLINE:

Patients receive ixabepilone intravenously (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 up every 3 months for 2 years and then every 6 months for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Tumor Response [ Time Frame: Every other cycle for the 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. ]
    Complete and Partial Tumor Response as assessed by RECIST 1.1
  • Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 [ Time Frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment ]


Original Primary Outcome:

  • Frequency and duration of objective response (complete or partial response) as measured by RECIST
  • Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0


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.
  • 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: October 12, 2010
Date Started: November 2010
Date Completion:
Last Updated: July 22, 2016
Last Verified: July 2016