| Eligibility |
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.
Exclusion Criteria:
- The subject has had chemotherapy, immunotherapy, hormonal tx (other than HRT for
menopause), or RT within 3 wks of the Baseline visit.
- The subj has not recovered from the acute toxic effects of chemotherapy,
immunotherapy, hormonal tx, or RT.
- The subj will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for
menopause), or immunotherapy during the time of study.
- The subj has a history of hypersensitivity to sulindac, COX-2 inhibitors, NSAIDs,
salicylates.
- The subj has been diagnosed with or has been treated for esophageal, gastric, pyloric
channel, or duodenal ulceration.
- The subj has a history of inv cancer within the past 1 yr (excluding non-melanoma skin
cancer and in situ cervical cancer).
- The subj has a chronic or acute renal or hepatic disorder or a significant bleeding
disorder or any other condition which, in the Institutional Principal Investigator's
opinion, might preclude study participation.
- The subj has a past history of or active inflammatory bowel disease (eg. Crohn's
disease or ulcerative colitis) or pancreatic disease.
- The subj has received any investigational medication within 30 ds of the Baseline
visit or is scheduled to receive an investigational drug during the course of the
study.
- The subj is, in the opinion of the Institutional Principal Investigator, not an
appropriate candidate for study participation.
- The subj participated in the study previously and was withdrawn.
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