Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer (ENDORAD)
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|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|
|Actual Primary Completion Date :||May 2011|
|Experimental: Single arm||
- Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|