Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | March 2015 |
| End Date: | March 2021 |
A Phase I Dose-finding Study of Metformin in Combination With Concurrent Cisplatin and Radiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
The purpose of this research study is to test the safety of adding metformin to standard of
care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments
and radiation for 7 weeks.
Metformin is a medication that is currently used to treat diabetes. Increasing amounts of
metformin will be given to groups of patients already receiving normal treatment for their
cancer to see if metformin causes any good effects by killing your cancer or bad effects
(side effects).
care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments
and radiation for 7 weeks.
Metformin is a medication that is currently used to treat diabetes. Increasing amounts of
metformin will be given to groups of patients already receiving normal treatment for their
cancer to see if metformin causes any good effects by killing your cancer or bad effects
(side effects).
Inclusion Criteria:
- Locally advanced squamous cell cancer of the head and neck, stage III or IV disease
(T1-2, N2a-3 or T3-4).
- Measurable disease
- No prior chemotherapy or radiation for head and neck squamous cell cancer
- Life expectancy of greater than 3 months.
- Adequate labs
Exclusion Criteria:
- Known metastatic disease.
- Nasopharyngeal carcinoma
- History of allergic reactions attributed to metformin or other agents used in study.
- Known diagnosis of diabetes requiring insulin for control.
- Administration of metformin within last 4 weeks.
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