Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study
- Determine the response rate, in terms of prostaglandin E2 expression, in patients with
oral leukoplakia and/or dysplasia treated with celecoxib.
- Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF,
and CD31, in patients treated with this drug.
- Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia
lesions and presence of dysplasia, in these patients.
- Correlate change in biomarker expression with response of oral leukoplakia lesions
and/or dysplasia in patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a
repeat biopsy. Patients with a positive response receive celecoxib for an additional 9
Patients are followed every 3-6 months for 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Prevention
Lori J. Wirth, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|