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 potential (women are considered not of childbearing potential if they are at least 2 yrs postmenopausal and/or surgically sterile), she:
• •* has been using adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since her last menses and will use adequate contraception during the study, AND
• •* is not lactating, AND
• •* has a documented negative serum pregnancy test within 14 ds prior to randomization.
• •The subj's history/use of NSAIDs, aspirin, corticosteroids meets the following criteria:
• •* total oral/intravenous corticosteroid use has been \< 14 ds within 6 mos of the Baseline visit, and
• •* total inhaled corticosteroid use has been \< 30 ds within 6 mos of the Baseline visit, and
• •* is willing to limit aspirin use to \< or = 120 mg po per d (typical cardioprotective dose in India) or \< or = 80 mg po per d (typical cardioprotective dose in the US) for the duration of the study, and is willing to abstain from chronic use of all NSAIDs and COX-2 inhibitors for duration of study. Chronic use of NSAIDs is defined as a frequency of \> or = 3 times/wk AND for more than a total of 14 ds a yr.
• •The subj has discontinued any other chemopreventive therapy at least 3 mos prior to the Baseline visit and all toxicities have been fully resolved.
• •If applicable, the subj has been counseled on smoking cessation.
• •If the subject is male, will use adequate contraception during the study.