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Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Cancer focused on measuring esophageal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center - Tucson
  • Jonsson Comprehensive Cancer Center, UCLA
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Mayo Clinic Cancer Center
  • Herbert Irving Comprehensive Cancer Center
  • Ireland Cancer Center
  • Veterans Affairs Medical Center - Portland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
October 12, 2016
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005878
Brief Title
Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
Official Title
Chemoprevention for Barrett's Esophagus Trial (CBET)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene A. Forastiere, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17405999
Citation
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.
Results Reference
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Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

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