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Protocol No. UW16110

Principal Investigator Wieland, Aaron

Phase II (Cancer Prevention)

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

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

Objective The purpose of this study is to learn about the safety and effects of ACTOplus met® XR on people and their risk of cancers of the head or neck. We hope to learn more about the potential for ACTOplus met® XR to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers.

Treatment In this study, you will get either ACTOplus met® XR or a placebo (a tablet that looks like the study drug but contains no medication). ACTOplus met® XR is a medication that is approved by the Food and Drug Administration to help improve blood sugar (glucose) control in adults with type 2 diabetes. It is a combination of two medications that work differently to control blood sugar: pioglitazone (also called Actos) and metformin. The XR in the name stands for extended release (the metformin part of the tablet is released slowly into your body). Research shows that both pioglitazone and metformin have some anti-cancer effects.

Description A total of 39 people will be included in this study. They will be divided into two study groups. Group 1 will receive ACTOplus met® XR. Group 2 will receive a placebo. Two out of every three people on the study will be in the ACTOplus met® XR group. One out of every three people will be in the placebo group. The study medication is taken for 14 to 21 days before treatment for your cancer starts. The dose is one tablet per day by mouth with a meal. ACTOplus met® XR is not a treatment for your cancer and participating in this study will not change or substitute for the usual treatment.

Key Eligibility
  • Participant has a newly diagnosed, histologically confirmed, stage I-IV squamous cell carcinoma of the oral cavity or oropharynx and will be undergoing definitive surgical, radiotherapy, or chemoradiation treatment OR participant has a lesion in the oral cavity or oropharynx that is not yet biopsied but is highly suspicious for cancer
  • The participant's primary tumor is accessible to biopsy in the outpatient clinic setting and the participant is willing to have baseline and end of study biopsies of tumor and adjacent visually normal appearing tissue for biomarker analysis
  • Participant is able to complete a minimum of 14 days of study agent dosing prior to initiation of definitive treatment for their cancer
  • Age ≥18 years
  • ECOG performance status = 0 or 1
  • Body mass index (BMI) is ≥ 18.5
  • Participant of childbearing potential agrees to use adequate contraception for the duration of their study participation
  • Participants who have received or will receive some form of treatment for their cancer prior to completing a minimum of 14 days of study agent dosing are ineligible
  • Participant has a concurrent diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent are ineligible
  • Participants with a history of congestive heart failure or New York Heart Association (NYHA) Class III or IV functional status are ineligible
  • Participants with a history of liver disease are ineligible
  • Participant who are active alcoholics or consume excessive amounts of alcohol are ineligible
  • Participants with a history of macular edema are ineligible
  • Participants who have a history of bladder cancer (including in situ bladder cancer) are ineligible
  • Participants who are pregnant, breast feeding or planning to become pregnant are ineligible

Applicable Disease Sites Head and Neck

Status Open

Participating Institutions Johns Hopkins University, Sidney Kimmel Comp Cancer Ctr; UW Hospital and Clinics; University of Minnesota, Masonic Cancer Center; University of Rochester, James P Wilmot Cancer Center