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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 : Completed
First Posted : December 25, 2014
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Trisha Wise-Draper, University of Cincinnati

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Metformin Drug: Cisplatin Radiation: Radiation Therapy Phase 1

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : December 26, 2017
Actual Study Completion Date : February 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin with Chemoradiation
Metformin administered orally daily to start one week prior to Cisplatin and Radiation Therapy. Metformin dose is escalating.
 Drug: Metformin
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

Drug: Cisplatin
Dosed at 100mg/m2 on days 1, 22, and 43
Other Names:
  • Platinol
  • Platinol-AQ

Radiation: Radiation Therapy
70 Gy in 2 Gy once daily fractions of 35 fractions


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Trisha Wise-Draper, MD University of Cincinnati
  Study Documents (Full-Text)

Documents provided by Trisha Wise-Draper, University of Cincinnati:
Study Protocol and Statistical Analysis Plan  [PDF] August 31, 2017
Informed Consent Form  [PDF] February 7, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02325401    
Other Study ID Numbers: UCCI-HN-14-01
First Posted: December 25, 2014    Key Record Dates
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Metformin
Cisplatin
Antineoplastic Agents
Hypoglycemic Agents
Physiological Effects of Drugs