Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.

Detailed Description
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OBJECTIVES: Determine the safety and efficacy of celecoxib for regression of Barrett's dysplasia in patients with low or high-grade dysplasia of the esophagus. OUTLINE: This is a randomized, parallel, double-blind, placebo-controlled, multicenter study. Patients are stratified according to center and grade of dysplasia at baseline (low vs high). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral celecoxib twice daily for 48-96 weeks. Arm II: Patients receive oral placebo as in arm I. Treatment continues in both arms in the absence of unacceptable toxicity or development of adenocarcinoma of the esophagus or cancer at other sites. Patients are followed at 12 weeks. PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study.

Official Title
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Chemoprevention for Barrett's Esophagus Trial (CBET)

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer