Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 Clinical Trial
Official title:
Phase IIB Randomized, Placebo-Controlled Trial of ACTOplus Met® XR in Subjects With Stage I-IV Squamous Cell Carcinoma of the Oral Cavity or Oropharynx Prior to Definitive Treatment
This randomized phase IIb trial studies how well ACTOplus met extended release (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.
PRIMARY OBJECTIVES: I. To determine whether 10-21 days of treatment with ACTOplus met XR will result in a decrease in proliferation index (Ki-67) expression in oral cavity/oropharyngeal tumor tissue as compared to placebo. SECONDARY OBJECTIVES: I. Compare differences in proliferation index (Ki-67) expression from baseline to post-exposure in visually normal appearing oral cavity/oropharyngeal tissue. II. Compare immunohistochemical differences in the apoptosis biomarker cleaved caspase 3 from baseline to post-exposure in oral cavity/oropharyngeal adjacent visually normal appearing tissue and tumor tissue samples. III. Compare immunohistochemical differences from baseline to post-exposure in oral cavity/oropharyngeal tumor tissue samples with regard to cyclin D1, p21 and biguanide or PPAR gamma associated pathway biomarkers; prospective biomarkers on the panel will include phosphorylated (p)AKT, pAMPK, pS6 (metformin), and PPAR gamma. IV. Compare immunohistochemical differences from baseline to post-exposure of oral cavity/oropharyngeal tumor tissue samples with regard to tumor infiltrating immune cells (effector CD8 [CD8+]), regulatory CD4 T regulatory (Treg) (CD4+Foxp3+), tumor associated myeloid cells (CD68), PD1 and PD-L1. V. Compare and correlate pre- and post-ACTOplus met XR treatment human ribonucleic acid (RNA)-sequencing (seq) gene analysis on total RNA samples from oral cavity/oropharyngeal adjacent visually normal appearing tissue and tumor tissue pre-and post-study treatment. VI. Determine human papillomavirus (HPV) status in pre-treatment tumor tissue using p16 immunohistochemistry. EXPLORATORY OBJECTIVES I. Compare pre- and post-study treatment fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scans with regard to standardized uptake value (SUV) of FDG and tumor burden using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 in those participants with a preintervention standard of care staging FDG-PET/CT. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive ACTOplus met XR orally (PO) once daily (QD) for 10-21 days in the absence of disease progression or unacceptable toxicity. Patients may continue ACTOplus met XR PO QD for a maximum of 25 days if end of treatment biopsy/surgical treatment is delayed beyond day 22. GROUP II: Patients receive placebo PO QD daily for 10-21 days. ;
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