The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Ridaforolimus in Treating Patients With Recurrent Metastatic and/or Locally Advanced Endometrial Cancer
Official Title: A Phase II Study of Ridaforolimus in Patients With Metastatic And/Or Locally Advanced Recurrent Endometrial Cancer
Study ID: NCT00770185
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
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
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Name: Amit M. Oza, MD
Affiliation: Princess Margaret Hospital, Canada
Role: STUDY_CHAIR