N/A
N=63
A Randomized Study of Sulindac in Oral Premalignant Lesions
Leukoplakia, Oral · Benign Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00299195 ↗Enrolled (actual)
63
Serious AEs
9.5%
Results posted
Nov 2020
Primary outcome: Primary: - To Evaluate the Efficacy of Sulindac in Subjects With Early or Advanced Oral Premalignant Lesion (OPL) by Both Clinical Response (Reduction in Size of All Lesions) and Histological Response (Change in Histological Grade).
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sulindac (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY - To Evaluate the Efficacy of Sulindac in Subjects With Early or Advanced Oral Premalignant Lesion (OPL) by Both Clinical Response (Reduction in Size of All Lesions) and Histological Response (Change in Histological Grade). |
— | — |
| SECONDARY To Evaluate the Effect of Sulindac in Modulating the Expression of the Intermediate Biomarkers Ki67, p53 Proteins and DNA Ploidy After 24 Weeks of Treatment of Study Drug, and Again After 8 Weeks Off Study Drug. |
— | — |
| SECONDARY To Evaluate the Correlation Between Baseline COX-2 Expression or DNA Ploidy With Clinical Response or Biomarker Modulation |
— | — |
| SECONDARY To Evaluate the Safety of Chronic Dosing of Sulindac in This Subject Population |
— | — |
| SECONDARY To Explore the Relationship Between Genetic Polymorphisms of Genes Involved in Carcinogenesis and Clinical or Biomarker Response to Sulindac |
— | — |
Summary
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. Sulindac is an anti-inflammatory drug that has already been tested in people with arthritis (inflammation of a joint).
This study is being done by Memorial Sloan-Kettering Cancer Center in New York, Amrita Institute of Medical Sciences and Research Center in Cochin, India, and Regional Cancer Centre (RCC) in Trivandrum, India.
Eligibility Criteria
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 = 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.
Data sourced from ClinicalTrials.gov (NCT00299195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.