Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

Phase 2 Completed Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI) · collab

RandomizedDouble-blindPrevention

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.

Timeline

Start: 2000-07
Primary completion: 2005-09
Completion: 2005-09

Outcome

Missed primary endpoint

paper no difference was observed in the median change in the proportion of biopsy samples with dysplasia or cancer between treatment groups PMID 17405999 ↗

paper with celecoxib = -0.09, interquartile range [IQR] = -0.32 to 0.14 and with placebo = -0.07, IQR = -0.26 to 0.12; P = .64 PMID 17405999 ↗

Publications

Results Heath EI, Canto MI, Piantadosi S, Montgomery E, Weinstein WM, Herman JG, Dannenberg AJ, Yang VW, Shar AO, Hawk E, Forastiere AA; Chemoprevention for Barrett's Esophagus Trial Research Group. Secondary chemoprevention of Barrett's esophagus with celecoxib: results of a randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):545-57. doi: 10.1093/jnci/djk112.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	200 mg	Oral