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Pilot Study of Sulindac, a Pan-COX Inhibitor, in Oral Premalignant Lesions

[Protocol 04-099]

Full Title :
A PILOT MULTI-CENTER INTERNATIONAL DOUBLE-BLIND PLACEBO CONTROLLED RANDOMIZED STUDY OF SULINDAC, A PAN-COX INHIBITOR, IN ORAL PREMALIGNANT LESIONS
Purpose :

Oral intraepithelial neoplasm (white or red patches of oral cavity) is a precancerous condition of the mouth. People with pre-cancerous mouth growths are at greater risk of developing mouth cancer compared to those who do not have such growths.

The purpose of this study is to see if a drug called sulindac can prevent the development of changes in the mouth that are related to oral pre-cancer growths (oral epithelial dysplasia) or oral cancer. There is no standard medical treatment for this condition.

Sulindac, a capsule that is taken orally, is an anti-inflammatory drug that has already been approved for treating arthritis. It works by inhibiting an enzyme involved in inflammation. Patients in this study will be randomly assigned to receive sulindac or a placebo for six months.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have at least one oral precancer that is 12 mm or greater in size.
  • Participants may not have had chemotherapy, immunotherapy, hormonal therapy (other than hormone replacement therapy for menopause), or radiation therapy within 3 weeks of the initial visit.
  • Participants who use aspirin regularly must be willing to limit their aspirin use during the study. Those who take NSAIDs regularly must be willing to abstain from their use during the study.
  • Patients who have or have had esophageal gastric, pyloric channel, or duodenal ulceration, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or pancreatic disease may not participate.
  • Participants must be over age 18.

For more information and to see if you are eligible for this study, please contact Helen Leung at 646-735-8071 or leungh@mskcc.org.

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