Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

Phase 2 Completed 93 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupDouble-blindPrevention

Summary

This randomized phase II trial studies how well metformin hydrochloride works in preventing esophageal cancer in patients with Barrett esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may keep esophageal cancer from forming.

Timeline

Start: 2012-06
Primary completion: 2013-05
Completion: 2013-09

Outcome

Missed primary endpoint

paper The percent change in median level of pS6K1 did not differ significantly between groups PMID 25218668 ↗

Publications

Chak A, Buttar NS, Foster NR, Seisler DK, Marcon NE, Schoen R, Cruz-Correa MR, Falk GW, Sharma P, Hur C, Katzka DA, Rodriguez LM, Richmond E, Sharma AN, Smyrk TC, Mandrekar SJ, Limburg PJ; Cancer Prevention Network. Metformin does not reduce markers of cell proliferation in esophageal tissues of patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2015 Apr;13(4):665-72.e1-4. doi: 10.1016/j.cgh.2014.08.040. Epub 2014 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	2000 mg	Oral