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

Endometrial Adenocarcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00072176
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date May 2004
Completion date August 2009
View Details
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