Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Genetic: gene expression analysisOther: immunohistochemistry staining methodOther: laboratory biomarker analysis
- Registration Number
- NCT00770185
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Ridaforolimus 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 the side effects of ridaforolimus and to see how well it works in treating patients with recurrent metastatic and/or locally advanced endometrial cancer.
- Detailed Description
OBJECTIVES:
* To assess the efficacy, in terms of objective response rate, of ridaforolimus, in patients with recurrent metastatic and/or locally advanced endometrial cancer.
* To assess the adverse events, time to progression, and response duration of this drug in these patients.
* To correlate objective tumor response with PTEN expression and other potential markers in primary tumor tissue from these patients.
OUTLINE: This is a multicenter study.
Patients receive oral ridaforolimus once daily on days 1-5 for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples (paraffin block or unstained slides) are analyzed for PTEN gene expression and other mTOR pathway elements to explore possible markers of response or non-progression by immunohistochemistry.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ridaforolimus ridaforolimus oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period) Ridaforolimus gene expression analysis oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period) Ridaforolimus immunohistochemistry staining method oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period) Ridaforolimus laboratory biomarker analysis oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
- Primary Outcome Measures
Name Time Method Objective response measured by RECIST criteria every 8 weeks After every second cycle
Adverse events 4 years Adverse events will be monitored and assessed from the time of the first dose with overall results being assessed at final analysis.
Time to progression 4 years Correlation between objective tumor response with PTEN expression and other potential markers 4 years will be assessed overall at the time of completion of therapy and final analysis.
- Secondary Outcome Measures
Name Time Method Response duration 4 years After progression with overall results assessed at final analysis
Trial Locations
- Locations (11)
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada