ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment

This randomized phase IIb trial studies how well ACTOplus met XR works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or coming back. The use of ACTOplus met XR may slow disease progression in patients with oral cavity or oropharynx cancer.

Intervention

Laboratory Biomarker Analysis, Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet, Pharmacological Study, Placebo

Condition

Oral Cavity Neoplasm, Oropharyngeal Neoplasm, Stage I Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7

Investigators

Frank G. Ondrey, Wayne M. Koch, Paul M. Harari, Shawn D. Newlands

See list of participating sites