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Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy

Cancer Clinical Trial

Official title:
Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy

Clinical Trial Summary

Metformin is a drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. Future studies are envisioned to that test the efficacy of administering metformin with chemotherapy. The purpose of this study is to assess the safety of administering metformin in combination with chemotherapy. Since chemotherapy and cancer itself both cause adverse events by themselves, this study is designed to have a run-in stage as well as a subsequent randomization to metformin or no metformin. The primary endpoint will compare the rate of dose-limiting toxicities between these two arms. After a period of 3 weeks for the primary endpoint comparison, all patients will receive metformin.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01442870
Study type Interventional
Source Tufts Medical Center
Contact
Status Completed
Phase Phase 1
Start date September 2011
Completion date November 2014
View Details
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