Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

Phase 2 Completed 61 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupDouble-blindPrevention

Summary

This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.

Timeline

Start: 2006-08
Primary completion: 2010-05
Completion: 2010-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Arm A (Sulindac) vs Arm B (Placebo); p = 0.85; Fisher Exact NCT00368927 ↗

paper these distributions were not statistically different (p=0.85). PMID 23261228 ↗

Publications

Limburg PJ, Mandrekar SJ, Aubry MC, Ziegler KL, Zhang J, Yi JE, Henry M, Tazelaar HD, Lam S, McWilliams A, Midthun DE, Edell ES, Rickman OB, Mazzone P, Tockman M, Beamis JF, Lamb C, Simoff M, Loprinzi C, Szabo E, Jett J; Cancer Prevention Network. Randomized phase II trial of sulindac for lung cancer chemoprevention. Lung Cancer. 2013 Mar;79(3):254-61. doi: 10.1016/j.lungcan.2012.11.011. Epub 2012 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sulindac	Small molecule	150 mg	Oral