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

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 11, 2015

Primary Completion Date

December 26, 2017

Study Completion Date

February 21, 2020

Conditions
Head and Neck Cancer
Interventions
DRUG

Metformin

Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.

DRUG

Cisplatin

Dosed at 100mg/m2 on days 1, 22, and 43

RADIATION

Radiation Therapy

70 Gy in 2 Gy once daily fractions of 35 fractions

Trial Locations (1)

45267

University of Cincinnati Cancer Institute, Cincinnati

All Listed Sponsors
lead

University of Cincinnati

OTHER

NCT02325401 - Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter