Chemoprevention for Barrett's Esophagus Trial (CBET)

Inclusion 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