Tobacco Use Disorder Clinical Trial
Official title:
Randomized, Phase IIb Trial of Sulindac in Smokers With Bronchial Dysplasia
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.
PRIMARY OBJECTIVES:
I. Compare the change in histologic grade of bronchial dysplasia, as determined from mucosal
biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscopy
exams, in current or former smokers with bronchial dysplasia treated with sulindac vs
placebo.
SECONDARY OBJECTIVES:
I. Compare the change in number of dysplastic lesions, as determined from mucosal biopsy
samples obtained during pre- and post-intervention autofluorescence bronchoscopy exams, in
patients treated with these regimens.
II. Compare changes in tissue-based biomarkers (cyclooxygenase [COX]-2, 15-lipoxygenase
[LOX]-1, PPAR γ, Ki-67, caspase-3, cyclin D1, cyclin E) in patients treated with these
regimens.
III. Determine the safety and adverse event profiles of these regimens in these patients.
IV. Describe the frequency and patterns of bronchial dysplasia as well as biomarker
characteristics in patients treated with this regimen.
V. Establish a biospecimen repository archive for future correlative studies.
OUTLINE: This is a multicenter, double-blind, randomized, placebo-controlled study. Patients
are stratified according to smoking status (current vs former), prior lung cancer (yes vs
no), and number of baseline dysplastic lesions (1-3 vs > 3). Patients are randomized to 1 of
2 treatment arms.
ARM I: Patients receive oral sulindac twice daily for 6 months.
ARM II: Patients receive oral placebo twice daily for 6 months. Bronchoscopic examination
and mucosal biopsy are performed at baseline and at completion of study treatment. Tissue
samples are examined by immunohistochemistry for biological markers, including Ki-67,
caspase-3, cyclooxygenase-2, cyclin D1, cyclin E, vascular endothelial growth factor, PPAR
γ, and 15-lipoxygenase-1. Blood samples are collected for serum cotinine.
After completion of study treatment, patients are followed for up to 30 days.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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