Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus

Phase 2 Completed 122 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupTriple-blindPrevention

Summary

This randomized phase II trial is studying the effect of esomeprazole magnesium and aspirin on tissue PGE2 levels compared with esomeprazole and placebo. This type of chemoprevention treatment investigates the use of certain drugs to assess whether they assist in the prevention of cancer. The use of esomeprazole magnesium with or without aspirin may help prevent esophageal cancer in patients with Barrett esophagus.

Timeline

Start: 2007-04
Primary completion: 2011-03
Completion: 2011-06

Outcome

Mixed primary results

registry Arm I (Placebo, Esomeprazole Magnesium) vs Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium); p = 0.0955; Wilcoxon (Mann-Whitney) NCT00474903 ↗

registry Arm I (Placebo, Esomeprazole Magnesium) vs Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium); p = 0.0204; Wilcoxon (Mann-Whitney) NCT00474903 ↗

paper In combination with esomeprazole, short-term administration of higher doses of aspirin, but not lower doses or no aspirin, significantly reduced tissue concentrations of PGE(2) PMID 22796132 ↗

Publications

Falk GW, Buttar NS, Foster NR, Ziegler KL, Demars CJ, Romero Y, Marcon NE, Schnell T, Corley DA, Sharma P, Cruz-Correa MR, Hur C, Fleischer DE, Chak A, Devault KR, Weinberg DS, Della'Zanna G, Richmond E, Smyrk TC, Mandrekar SJ, Limburg PJ; Cancer Prevention Network. A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. Gastroenterology. 2012 Oct;143(4):917-26.e1. doi: 10.1053/j.gastro.2012.06.044. Epub 2012 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	81 mg	Oral
Subject	Aspirin	Small molecule	325 mg	Oral
Background	Esomeprazole	Small molecule	40 mg	Oral