NCT01026792

Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery

A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. By blocking this protein cancer cells may stop growing or die.

Detailed description

PRIMARY OBJECTIVES: I. To assess the efficacy (objective response rate) of temsirolimus given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. II. To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. III. To explore the relationship between expression of proteins in the mammalian target of rapamycin (mTOR) pathway in archival tissue samples from patients on this trial and their objective response to therapy. OUTLINE: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months (patients with complete response \[CR\], partial response \[PR\], or stable disease \[SD\] only) thereafter.

Conditions

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Recurrent Cervical Carcinoma
• Stage IIIA Cervical Cancer
• Stage IIIB Cervical Cancer
• Stage IVA Cervical Cancer
• Stage IVB Cervical Cancer

Interventions

Type	Name	Description
DRUG	Temsirolimus	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2009-12-04
• Last updated: 2015-09-10
• Results posted: 2015-09-10

Locations

1 site across 1 country: Canada