Temsirolimus in Treating Patients With Locally Advanced or Metastatic Cervical Cancer That Cannot Be Removed By Surgery
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with locally advanced or metastatic cervical cancer that cannot be removed by surgery.
Genetic: promoter methylation analysis
Genetic: fluorescence in situ hybridization
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix|
- Objective response as assessed by RECIST criteria [ Time Frame: after completion of therapy ] [ Designated as safety issue: No ]
- Time to progression and response duration [ Time Frame: after completion of therapy ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: after completion of therapy ] [ Designated as safety issue: Yes ]
- Relationship between expression of proteins in the mTOR pathway in archival tissue samples and objective response to therapy [ Time Frame: after completion of therapy ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- To assess the efficacy of temsirolimus, in terms of objective response rate, in patients with unresectable, locally advanced or metastatic carcinoma of the cervix.
- To assess the time to progression and response duration in patients treated with this drug.
- To assess the adverse events associated with this drug in these patients.
- To explore the relationship between expression of proteins in the mTOR pathway in archival tissue samples and objective response to therapy.
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue sample collection for laboratory biomarker studies, including analysis of PTEN expression by IHC, PTEN promoter methylation, and PTEN genomic losses and PIK3CA copy number by FISH.
After completion of study therapy, patients are followed up at 4 weeks and then every 3 months thereafter until relapse/progression.
|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 - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|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|
|Study Chair:||Anna Tinker, MD||British Columbia Cancer Agency|
|Study Chair:||Helen MacKay, M.D||University Health Network - Princess Margaret Hospital|