Phase IIB Randomized, Placebo-Controlled Trial of ACTOplus met® XR in Subjects with Stage I-IV Squamous Cell Carcinoma of the Oral Cavity of Oropharynx Prior to Definitive Treatment

拟议的临床试验将讨论吡格列酮和二甲双胍(ACTOplus MET®XR)的联合应用在预防口腔和口咽癌方面是否具有潜在的实用价值。对于I-IV期口腔或口咽癌患者，在接受手术、放疗或化疗的最终治疗之前，市场上销售的二甲双胍XR 1000毫克和吡格列酮30毫克的组合每天服用14-21天，这是IIb期试验的机会之窗。目的是确定药物组合对肿瘤和周围视觉正常上皮中的各种组织生物标记物的影响。该试验将在明尼苏达大学、罗切斯特大学、约翰霍普金斯大学和威斯康星大学进行，并由威斯康星大学监督。

The proposed clinical trial shall address whether the combination of pioglitazone and metformin (ACTOplus met® XR) has potential utility in the prevention of oral and oropharyngeal cancer. It is a phase IIb window of opportunity trial of the marketed combination of metformin XR 1,000 mg and pioglitazone 30 mg per day given for 14-21 days in patients with stage I-IV oral cavity or oropharyngeal cancer prior to definitive therapy with surgery, radiation, or chemoradiation. The goal is to determine the effects of the drug combination on a variety of tissue biomarkers, both in the tumor and in the surrounding visually normal epithelium. The trial shall be performed at the University of Minnesota, University of Rochester, Johns Hopkins University, and University of Wisconsin under the oversight of the University of Wisconsin.