Celecoxib in Treating Patients With Precancerous Lesions of the Mouth

Phase 2 Completed Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI) · collab

Prevention

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the further development of precancerous lesions in the mouth. PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of celecoxib in treating patients who have precancerous lesions in the mouth.

Timeline

Start: 2000-10
Primary completion: 2006-01
Completion: —

Outcome

Missed primary endpoint

paper Celecoxib at 100 or 200 mg twice daily was ineffective in controlling OPLs in this randomized controlled trial. PMID 18381950 ↗

Publications

Results Papadimitrakopoulou VA, William WN Jr, Dannenberg AJ, Lippman SM, Lee JJ, Ondrey FG, Peterson DE, Feng L, Atwell A, El-Naggar AK, Nathan CO, Helman JI, Du B, Yueh B, Boyle JO. Pilot randomized phase II study of celecoxib in oral premalignant lesions. Clin Cancer Res. 2008 Apr 1;14(7):2095-101. doi: 10.1158/1078-0432.CCR-07-4024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	100 mg	Oral
Subject	Celecoxib	Other / unclassified	200 mg	Oral
Subject	Celecoxib	Other / unclassified	400 mg	Oral