Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

Completed · Phase 1

Conditions studied: Head and Neck Cancer

In brief

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).

Key facts

Study ID

NCT02325401

Run by

University of Cincinnati

People needed

20

Starts

2015-05-11

Expected to finish

2020-02-21

Last updated by the study team

2020-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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