Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

Summary

The purpose of this research is to see whether metformin can improve the response rate in patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx. The purpose of this research is also to see the effects, good and bad, of metformin therapy for this disease. Researchers will also analyze tumor and blood samples from study patients to test and understand the characteristics of tumors which respond to metformin.

Timeline

Start

2017-01-26

Primary completion

2021-06-28

Completion

2022-07-07

Outcome

Met primary endpoint

paper The primary outcome for the Phase II component was met with a response rate of 96%. PMID 37562095 ↗

Publications

• Kemnade JO, Florez M, Sabichi A, Zhang J, Jhaveri P, Chen G, Chen A, Miller-Chism C, Shaun B, Hilsenbeck SG, Hernandez DJ, Skinner HD, Sandulache VC. Phase I / II trial of metformin as a chemo-radiosensitizer in a head and neck cancer patient population. Oral Oncol. 2023 Oct;145:106536. doi: 10.1016/j.oraloncology.2023.106536. Epub 2023 Aug 8.

Drugs

Indications