Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02325401|
Recruitment Status : Active, not recruiting
First Posted : December 25, 2014
Last Update Posted : May 2, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Metformin Drug: Cisplatin Radiation: Radiation Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Metformin with Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
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.
Dosed at 100mg/m2 on days 1, 22, and 43
Radiation: Radiation Therapy
70 Gy in 2 Gy once daily fractions of 35 fractions
- Maximum tolerated dose (MTD) of metformin in combination with concurrent cisplatin and radiation [ Time Frame: 24 months ]
- Anti-tumor effect of metformin to chemoradiation [ Time Frame: 36 months ]
- Number of participants with adverse events [ Time Frame: 36 months ]
- Progression free survival [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325401
|United States, Ohio|
|University of Cincinnati Cancer Institute|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Trisha Wise-Draper, MD||University of Cincinnati|