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Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

Chemoprevention for Barrett's Esophagus Trial (CBET)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005878
Enrollment
Unknown
Registered
2003-01-27
Start date
2000-07-31
Completion date
2005-09-30
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

esophageal cancer

Brief summary

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

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.

Interventions

DRUGcelecoxib

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026