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

Phase 1

Completed

• Conditions: Endometrial Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Kidney Cancer; Lung Cancer; Breast Cancer; Lymphoma

• Registration Number: NCT00659568
• Lead Sponsor: London Health Sciences Centre

Brief 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2010-02
• Status Verified: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus

Secondary Outcome Measures

Name	Time	Method
Objective response
Frequency and severity of adverse events
Toxicity and safety, with particular reference to glucose and lipid deregulation
Survival
Antitumor activity, including tumor response rate and time to progression

Trial Locations

Locations (1)

London Regional Cancer Program at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada