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

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: Metformin (Drug); Cisplatin (Drug); Radiation Therapy (Radiation)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Nooshin Hashemi, MD, Principal Investigator, Affiliation: University of Cincinnati

Overall contact:
UC Cancer Institute Clinical Trials Office, Phone: 513-584-7698, Email: kastla@ucmail.uc.edu

Summary

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).

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum tolerated dose (MTD) of metformin in combination with concurrent cisplatin and radiation

Secondary outcome:

Anti-tumor effect of metformin to chemoradiation

Number of participants with adverse events

Progression free survival

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

UC Cancer Institute Clinical Trials Office, Phone: 513-584-7698, Email: kastla@ucmail.uc.edu

University of Cincinnati Cancer Institute, Cincinnati, Ohio 45267, United States; Recruiting
UC Cancer Institute Clinical Trials Office, Phone: 513-584-7698, Email: kastla@ucmail.uc.edu
Additional Information

Starting date: March 2015
Last updated: March 30, 2015

Page last updated: August 23, 2015

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