Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

NCT00005878 | Completed Phase 2

• 5 other identifiers: JHOC-J9932, CDR0000067917P30CA006973JHOC-J9932JHOC-99061108NCI-P00-0145
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Esophageal Cancer

Keywords

esophageal cancer

Interventions

celecoxib DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

Related Publications (1)

• 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: results of a randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):545-57. doi: 10.1093/jnci/djk112.

  PMID: 17405999 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arlene A. Forastiere, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

US (8)