NCT00072176

Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer

A Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy (response rate \& duration of stable disease) of CCI-779 (temsirolimus) given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. II. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. III. To correlate objective tumor response with phosphatase and tensin homolog gene (PTEN) expression in the tumor tissue obtained at diagnosis (primary tumor). IV. To explore the relationship between objective tumor response with other molecular measures in diagnostic tumor tissue. OUTLINE: 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 treatment, patients are followed up at 4 weeks and then every 3 months.

Conditions

• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Cell Carcinoma
• Endometrial Clear Cell Carcinoma
• Endometrial Papillary Serous Carcinoma
• Recurrent Endometrial Carcinoma
• Stage IIIA Endometrial Carcinoma
• Stage IIIB Endometrial Carcinoma
• Stage IIIC Endometrial Carcinoma
• Stage IVA Endometrial Carcinoma
• Stage IVB Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	temsirolimus	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-05-01
• Primary completion: 2009-05-01
• Completion: 2009-08-01
• First posted: 2003-11-06
• Last updated: 2015-02-23
• Results posted: 2015-02-23

Locations

1 site across 1 country: Canada