A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix
- 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
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response as assessed by RECIST criteria
after completion of therapy
Anna Tinker, MD
British Columbia Cancer Agency
Canada: Health Canada