Spots Global Cancer Trial Database for Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
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Trial Identification
Brief Title: Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Official Title: Pilot Phase II Study of Temsirolimus in Patients With Recurrent Mixed Mesodermal and Mullerian Tumors (Carcinosarcoma) of the Uterus
Study ID: NCT01061606
Interventions
Study Description
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 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Tower Cancer Research Foundation, Beverly Hills, California, United States
City of Hope, Duarte, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
City of Hope Medical Group Inc, Pasadena, California, United States
University of California at Davis Cancer Center, Sacramento, California, United States
University of Connecticut, Farmington, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
The Valley Hospital-Luckow Pavilion, Paramus, New Jersey, United States
Women's Cancer Care Associates LLC, Albany, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Beth Israel Medical Center, New York, New York, United States
New York University Langone Medical Center, New York, New York, United States
Saint Luke's Roosevelt Hospital Center - Roosevelt Division, New York, New York, United States
Presbyterian-Weill Medical College, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Children's Hospital of New York Presbyterian, New York, New York, United States
Columbia University College of Physicians and Surgeons, New York, New York, United States
Penn State Hershey Children's Hospital, Hershey, Pennsylvania, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: Mark Einstein
Affiliation: Montefiore Medical Center - Moses Campus
Role: PRINCIPAL_INVESTIGATOR
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