Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer (ENDORAD)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer|
- Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870337
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Principal Investigator:||Laure Chauvenet, MD||Hotel Dieu de Paris|