This phase II trial is studying how well temsirolimus works in treating patients with recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Assess the efficacy of Temsirolimus in women with recurrent or persistent (after primary therapy) Carcinosarcoma (MMMT) of the uterus. II. Assess the safety and tolerability of Temsirolimus in this patient population. III. Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival (PFS), 6 month PFS rate, and duration of response. SECONDARY OBJECTIVES: I. Overall survival II.Duration of Response III. Time to progression IV. Time to treatment failure OUTLINE: This is a multicenter study. Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up periodically for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Given IV
Tower Cancer Research Foundation
Beverly Hills, California, United States
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST
Time frame: Up to 3 years
Progression Free Survival
The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.
Time frame: 6 months from registration
Overall Survival
Time to event distributions will be estimated using the Kaplan-Meier method.
Time frame: From registration to death, assessed up to 3 years
Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient's Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented
Median duration of response and the confidence interval for the median duration will be computed.
Time frame: Up to 3 years
Time to Treatment Failure
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
Time frame: From study registration to the date patients end treatment, assessed up to 3 years
Time to Progression
Time frame: Time to progression is defined as the time from registration to disease progression.
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