Clinical Trial: Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Pilot Phase II Study of Temsirolimus in Patients With Recurrent Mixed Mesodermal and Mullerian Tumors (Carcinosarcoma) of the Uterus

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • 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 [ Time Frame: 6 months from registration ]
    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.


Original Primary Outcome:

  • Tumor response rate as measured by RECIST criteria
  • 6-month progression-free survival rate


Current Secondary Outcome:

  • Overall Survival [ Time Frame: From registration to death, assessed up to 3 years ]
    Time to event distributions will be estimated using the Kaplan-Meier method.
  • 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 [ Time Frame: Up to 3 years ]
    Median duration of response and the confidence interval for the median duration will be computed.
  • Time to Treatment Failure [ Time Frame: From study registration to the date patients end treatment, assessed up to 3 years ]
    Time to treatment failure will be evaluated using the method of Kaplan-Meier.
  • Time to Progression [ Time Frame: Time to progression is defined as the time from registration to disease progression. ]


Original Secondary Outcome:

  • Overall Survival
  • Duration of response
  • Time to disease progression
  • Time to Treatment Failure


Information By: National Cancer Institute (NCI)

Dates:
Date Received: February 2, 2010
Date Started: January 2010
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016