Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer
- Registration Number
- NCT00870337
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm everolimus -
- Primary Outcome Measures
Name Time Method Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hotel Dieu de Paris
🇫🇷Paris, France