Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer
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.
Genetic: gene expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Ridaforolimus in Patients With Metastatic And/Or Locally Advanced Recurrent Endometrial Cancer|
- Objective response measured by RECIST criteria [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]After every second cycle
- Adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Correlation between objective tumor response with PTEN expression and other potential markers [ Time Frame: 4 years ] [ Designated as safety issue: No ]will be assessed overall at the time of completion of therapy and final analysis.
- Response duration [ Time Frame: 4 years ] [ Designated as safety issue: No ]After progression with overall results assessed at final analysis
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||February 2014|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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)
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)Genetic: gene expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis
- 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.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Amit M. Oza, MD||Princess Margaret Hospital, Canada|