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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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)
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
Objective response measured by RECIST criteria
After every second cycle
Time frame: every 8 weeks
Adverse events
Adverse events will be monitored and assessed from the time of the first dose with overall results being assessed at final analysis.
Time frame: 4 years
Time to progression
Time frame: 4 years
Correlation between objective tumor response with PTEN expression and other potential markers
will be assessed overall at the time of completion of therapy and final analysis.
Time frame: 4 years
Response duration
After progression with overall results assessed at final analysis
Time frame: 4 years
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BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
McGill University - Dept. Oncology
Montreal, Quebec, Canada
...and 1 more locations