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Home > "C" Clinical Trials Conditions > Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus  Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
For Condition: Esophageal Cancer
Status: No longer recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional,�Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArleneForastiere, Study Chair, Sidney Kimmel Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000067917; NCI-P00-0145,JHOC-J9932,JHOC-99061108
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005878
Other Esophageal Cancer Studies:
1. A Single Arm, Phase II Study of TNFerade™ gene therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer
2. Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
3. Bryostatin 1 Plus Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer or Stomach Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
5. Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
Related Studies:
Other Esophageal Cancer Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
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