NCT00870337

Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	everolimus

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-05-01
• First posted: 2009-03-27
• Last updated: 2014-10-29

Locations

1 site across 1 country: France