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 chemoradiationNumber 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
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