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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Given IV
Correlative studies
Objective Tumor Response
Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
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
Adverse Events (Grade 3 or Higher) During Treatment Period.
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
Time frame: During treatment and up to 30 days after stopping the study treatment
Progression-free Survival
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
Time frame: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
Overall Survival
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time frame: From study entry to death or last contact, up to 5 years of follow-up.
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