Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
Esophageal Cancer
About this trial
This is an interventional prevention trial for Esophageal Cancer focused on measuring esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed Barrett's dysplasia with specific information on the location (level) of the highest grade of dysplasia based on biopsy from baseline endoscopy Short segment Barrett's esophagus must be sufficient area to allow for biopsy without complete resection No presence of reflux esophagitis grades 2-4 No history of confirmed invasive carcinoma of the esophagus No diagnosis of esophageal, gastric, pyloric channel, or duodenal ulceration of 1 cm or more in diameter within the past 30 days PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL Platelet count greater than 125,000/mm^3 WBC greater than 3,000/mm^3 No significant bleeding disorder No other abnormal hematopoietic laboratory test result that would preclude study Hepatic: PT/PTT no greater than 1.5 times upper limit of normal (ULN) AST/ALT less than 1.5 times ULN Alkaline phosphatase less than 1.5 times ULN No chronic or acute hepatic disorder No abnormal hepatic laboratory test result that would preclude study Renal: Creatinine no greater than 1.5 times ULN No chronic or acute renal disorder No other abnormal renal laboratory test result that would preclude study Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior or concurrent active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) No other prior or concurrent curatively treated malignancy with a survival prognosis of less than 5 years No hypersensitivity or adverse reaction to COX-2 inhibitors (e.g., celecoxib), sulfonamides, salicylates, or NSAIDs No other significant medical, psychological, or psychosocial condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 6 months since prior regular (at least 2 weeks duration) oral or intravenous corticosteroids At least 6 months since prior regular (at least 4 weeks duration) inhaled corticosteroids No concurrent regular oral or intravenous corticosteroids No concurrent regular inhaled corticosteroids Concurrent corticosteroid nasal spray allowed Radiotherapy: At least 12 weeks since prior radiotherapy to the chest or upper abdomen Surgery: At least 3 months since prior surgery to the esophagus or stomach except hiatal hernia repair, fundoplication, vagotomy, or pyloroplasty No prior complete mucosal resection using any technique No concurrent resection of high-grade nodule Other: At least 30 days since prior chronic (at least 3 times a week for greater than 2 weeks) aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) (i.e., greater than 100 mg/day) No prior complete mucosal ablation using any technique No prior treatment on this study At least 30 days since prior investigational medication including shingles vaccine No concurrent chronic NSAIDs or COX-2 inhibitors except low-dose aspirin (i.e., no greater than 100 mg/day) No concurrent anticoagulants (e.g., heparin or warfarin) No other concurrent investigational medication
Sites / Locations
- Veterans Affairs Medical Center - Tucson
- Jonsson Comprehensive Cancer Center, UCLA
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Mayo Clinic Cancer Center
- Herbert Irving Comprehensive Cancer Center
- Ireland Cancer Center
- Veterans Affairs Medical Center - Portland