Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy
Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus|
- 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
|Study Start Date:||November 2010|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220609
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|Principal Investigator:||Linda Duska||NRG Oncology|