A Randomized Study of Sulindac in Oral Premalignant Lesions

Inclusion Criteria: For this study an Oral Premalignant Lesions (OPL) is defined as a lesion which can include atypical hyperplasia, atypical hyperkeratosis, leukoplakia, and erythroplakia/erythro-leukoplakia. Histology MUST be confirmed by an MSKCC pathologist for all participating sites. An OPL may be located in the oral cavity, oropharynx. * The subj has a histologically suspected or confirmed index oral premalignant lesion, 12mm or greater in size that has not been bx'd in the past 6 wks. Each index lesion must be either: * An EARLY premalignant lesion defined to be at high risk as indicated by the presence of at least one of the following: atypical cells or mild dysplasia, or hyperplastic leukoplakia of high-risk sites, lateral and ventral tongue and floor or mouth OR * An ADVANCED premalignant lesion defined as the presence of at least one of the following: moderate dysplasia or severe dysplasia (excluding CIS) * The subj is \> 18 yrs of age * The subj's life expectancy is \> 12 wks and Zubrod performance status is 0 or 1 (Appendix VIII). * The subj meets the following lab eligibility criteria during a time not to exceed 4 wks prior to randomization. * Hemoglobin level above 10g/dL for women and above 12g/dL for men. * WBC count \> 3,000 uL. * Platelets count \> 125,000 uL. * Total bilirubin \< or = 1.5xULN * AST (SGOT) and ALT (SGPT) \< or = 2.5 x ULN. * BUN and serum creatinine \< or = 1.5 x ULN. * If the subj is female and of childbearing potentia…