Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer (ENDORAD)
|ClinicalTrials.gov Identifier: NCT00870337|
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : October 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: everolimus||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer|
|Study Start Date :||March 2008|
|Primary Completion Date :||May 2011|
|Experimental: Single arm||Drug: everolimus|
- Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870337
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Principal Investigator:||Laure Chauvenet, MD||Hotel Dieu de Paris|