Spots Global Cancer Trial Database for Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

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Trial Identification

Brief Title: Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

Official Title: Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer

Study ID: NCT00870337

Conditions

Endometrial Cancer

Interventions

everolimus

Study Description

Brief Summary: RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.

Detailed Description: OBJECTIVES: Primary * Estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer. Secondary * Evaluate the partial and complete response rate after 3 months of treatment with everolimus in these patients. * Evaluate the duration of response in these patients. * Evaluate the clinical benefit after 6 months of treatment with everolimus in these patients. * Evaluate the time to progression in these patients. * Evaluate the progression-free and overall survival of these patients. * Evaluate the nature, frequency, and severity of side effects of everolimus in these patients. OUTLINE: This is a multicenter study. Patients receive oral everolimus daily in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed monthly for 3 months and then every 3 months thereafter.