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Completed

NCT Number: NCT02325401

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

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).

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

About this study

Patients were registered by contacting the University of Cincinnati Clinical Trials Office. Patients must be registered and consent obtained prior to initiation of any protocol therapy.

Treatment was administered on an outpatient basis. Adverse events and potential risks for metformin and cisplatin and radiation were reported.

Patients must have screening labs performed within 2 weeks of start of treatment including a complete blood count, liver function tests, metabolic renal panel including magnesium, vitamin B12 level, lactate, and C-peptide. Renal panel must be verified within 24 hours of cisplatin administration. They must fulfill inclusion criteria.

The recommended starting dose of metformin in diabetic patients is 500mg orally twice a day which can be escalated by 500mg increments weekly as tolerated with the maximum recommended daily dose of 2550mg.

Cisplatin was given either before or after the radiation therapy fraction that is given on the same day. If radiation is held for more than 2 days (for any reason), cisplatin may be held as well until radiation resumes.

The prescribed radiotherapy dose was be 70 Gy in 2 Gy once-daily fraction size (total of 35 fractions).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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.

Other names: Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet

Cisplatin

Drug

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

Other names: Platinol, Platinol-AQ

radiation therapy

Radiation

70 Gy in 2 Gy once daily fractions of 35 fractions

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of Metformin in Combination With Concurrent Cisplatin and Radiation

    Time frame: 24 months

    Cohorts of patients received escalating doses of metformin (2000 mg, 2550 mg, or 3000 mg divided into daily doses) with a 7-day to 14-day lead-in prior to CRT based on the modified toxicity probability interval design to allow for possible re-escalation after previous de-escalation and to maximize the ability to identify the maximum tolerated dose (MTD). Patients continued to receive metformin for the duration of CRT as tolerated.

Secondary outcomes

  1. Number of Participants Experiencing No-Reoccurrence at 36 Months

    Time frame: 36 months

    Patients were evaulated at 36 months to determine if there was recurrence of disease.

  2. Number of Participants With Adverse Events

    Time frame: 36 months

    Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.Any participants with any adverse event at any grade was included. Adverse events were collected during the on study period of 21 weeks up to three months after the study for a total of 34 weeks.

  3. Progression Free Survival

    Time frame: 24 months

    2-year progression free survival

  4. Overall Survival

    Time frame: 24 months

    2 year overall survival

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Dec 25, 2014
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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