Phase 1
Completed N=20
Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov NCT02325401 ↗Enrolled (actual)
20
Serious AEs
44.4%
Results posted
Jun 2020
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation — NA; NA; NA mg
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation |
NA; NA; NA | — |
| SECONDARY Number of Participants Experiencing No-Reoccurrence at 36 Months |
6; 8; 4 | — |
| SECONDARY Number of Participants With Adverse Events |
6; 7; 4 | — |
| SECONDARY Progression Free Survival |
6; 8; 4 | — |
| SECONDARY Overall Survival |
5; 8; 4 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02325401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.