Trials / Completed

CompletedNCT00659568

Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma

A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 28 (estimated)

Sponsor: London Health Sciences Centre · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.

Detailed description

OBJECTIVES: Primary * To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma. Secondary * To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients. * To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen. OUTLINE: This is a dose-escalation study of metformin hydrochloride. Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Conditions

Interventions

Type	Name	Description
DRUG	metformin hydrochloride
DRUG	temsirolimus

Timeline

Start date: 2008-03-01
Primary completion: 2010-02-01
Completion: 2010-08-01
First posted: 2008-04-16
Last updated: 2013-05-30

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00659568. Inclusion in this directory is not an endorsement.