NCT01061606

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Recurrent Uterine Sarcoma
• Uterine Carcinosarcoma

Interventions

Type	Name	Description
DRUG	temsirolimus	Given IV

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-04-01
• Completion: 2012-10-01
• First posted: 2010-02-03
• Last updated: 2016-11-09
• Results posted: 2016-11-09

Locations

20 sites across 1 country: United States