Esophageal Cancer Clinical Trial
Official title:
Chemoprevention for Barrett's Esophagus Trial (CBET)
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | September 2005 |
Est. primary completion date | September 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Veterans Affairs Medical Center - Portland | Portland | Oregon |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Veterans Affairs Medical Center - Tucson | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Heath EI, Canto MI, Piantadosi S, Montgomery E, Weinstein WM, Herman JG, Dannenberg AJ, Yang VW, Shar AO, Hawk E, Forastiere AA; Chemoprevention for Barrett's Esophagus Trial Research Group. Secondary chemoprevention of Barrett's esophagus with celecoxib: — View Citation
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