Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

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