Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy|
- Incidence of dose limiting toxicity when metformin is added to chemotherapy [ Time Frame: 1 cycle (at least 3 weeks) ] [ Designated as safety issue: Yes ]The primary endpoint of the study will be to determine whether metformin can be safely added to a chemotherapy regimen that is previously well tolerated. The rate of dose limiting toxicities will be compared.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 cycle (at least 3 weeks) ] [ Designated as safety issue: Yes ]Secondary endpoints will include assessment of AEs ≥ grade 3 and Serious Adverse Events (SAEs), assessment of safety beyond the first cycle with metformin, and an exploration of metformin-chemotherapy drug interactions.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
No Intervention: No metformin
No metformin during primary endpoint assessment period (at least 3 weeks). Patients will subsequently be initiated on metformin.
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Wasif Saif, MD||Tufts Medical Center|