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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 : Active, not recruiting
First Posted : December 25, 2014
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Trisha Wise-Draper, University of Cincinnati

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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
Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of metformin in combination with concurrent cisplatin and radiation [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Anti-tumor effect of metformin to chemoradiation [ Time Frame: 36 months ]
  2. Number of participants with adverse events [ Time Frame: 36 months ]
  3. Progression free survival [ Time Frame: 24 months ]
  4. Overall survival [ Time Frame: 24 months ]


Information from the National Library of Medicine

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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.

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

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Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02325401     History of Changes
Other Study ID Numbers: UCCI-HN-14-01
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Metformin
Hypoglycemic Agents
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Cisplatin
Antineoplastic Agents
Physiological Effects of Drugs