Metformin Hydrochloride, Cisplatin and External Beam Radiation Therapy in Treating Participants with Stage III-IV Head and Neck Squamous Cell Cancer

Inclusion Criteria

• Patients must have histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx; patients eligible for inclusion must have stage III-IV SCC of the above sites based on current American Joint Committee on Cancer (AJCC) clinical and imaging based staging; only patients with human papillomavirus (HPV)- disease will be included in the phase II portion of the study; HPV status will be ascertained using the currently utilized clinical standard of p16 overexpression via immunohistochemistry
• Patients must have active, measurable disease to be included in the study
• Patients must have fully recovered (Eastern Cooperative Oncology Group [ECOG] 0-1) from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• Myelosuppressive chemotherapy: must not have received within 4 weeks of registration onto this study (6 weeks if prior nitrosourea)
• Hematopoietic growth factors: patients must be at least 7 days since the completion of therapy with a growth factor prior to registration
• Biologic (anti-neoplastic agent): patients must be at least 7 days since the completion of therapy prior to registration
• At least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody prior to registration
• Prior to registration, patients must be ≥ 14 days for local palliative radiation therapy (XRT) (small port); ≥ 90 days must have elapsed if prior total body irradiation (TBI), craniospinal XRT or if ≥ 50% radiation of pelvis; ≥ 45 days must have elapsed if other substantial bone marrow radiation
• Stem cell transplant or rescue: no evidence of active graft versus (vs.) host disease and ≥ 2 months must have elapsed since transplant prior to registration
• ECOG performance status less than or equal to 3
• Leukocytes ≥ 3,000/mcL within 14 days of registration
• Absolute neutrophil count ≥ 1,500/mcL within 14 days of registration
• Platelets ≥ 100,000/mcL within 14 days of registration
• Total bilirubin within normal institutional limits within 14 days of registration
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) ≤ 2.5X institutional upper limit of normal within 14 days of registration
• Alanine aminotransferase (ALT) / (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5X institutional upper limit of normal within 14 days of registration
• Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels > institutional normal within 14 days of registration
• Patients must be candidates for standard of care treatment consisting of chemotherapy (cisplatin) and radiation
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), 30 days prior to study drug initiation and 30 days post completion of study drug administration; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients must have the ability to understand and the willingness to sign a written informed consent document
• Patients may not be receiving any other investigational agents
• Patients may not have diagnosed brain metastases
• Patients may not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
• Patients may not have a diagnosis of diabetes mellitus as defined by: 1) known diagnosis of diabetes mellitus (DM), or 2) active treatment for DM, or 3) fasting glucose level ≥ 126 mg/dl, or 4) hemoglobin A1c ≥ 6.0% obtained within 30 days prior to registration
• Patients may not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients may not be pregnant or breastfeeding
• Patients may not have diagnosed human immunodeficiency virus (HIV)
• Patients may not be taking metformin for a reason other than study participation
• Patients may not have been treated for another SCC of the oral cavity, oropharynx, hypopharynx or larynx in the past