Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.