Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer — ENDORAD  

Endometrial Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT00870337
• Study type: Interventional
• Source: ARCAGY/ GINECO GROUP
• Status: Completed
• Phase: Phase 2
• Start date: March 2008