Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma
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|ClinicalTrials.gov Identifier: NCT00659568|
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Endometrial Cancer Kidney Cancer Lung Cancer Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Drug: metformin hydrochloride Drug: temsirolimus||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||February 2010|
|Study Completion Date :||August 2010|
- Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
- Toxicity and safety, with particular reference to glucose and lipid deregulation
- Antitumor activity, including tumor response rate and time to progression
- Objective response
- Frequency and severity of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659568
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Principal Investigator:||Mary Mackenzie, MD||London Health Sciences Centre|