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Brief Title: Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
Official Title: Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
Study ID: NCT01442870
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tufts Medical Center, Boston, Massachusetts, United States
Name: Wasif Saif, MD
Affiliation: Tufts Medical Center
Role: PRINCIPAL_INVESTIGATOR