Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005878 |
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.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: celecoxib |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Chemoprevention for Barrett's Esophagus Trial (CBET) |
Study Start Date: | July 2000 |
OBJECTIVES:
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.
Patients are followed at 12 weeks.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |
Veterans Affairs Medical Center - Tucson | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Illinois | |
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | |
Hines, Illinois, United States, 60141 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Veterans Affairs Medical Center - Portland | |
Portland, Oregon, United States, 97207 |
Study Chair: | Arlene A. Forastiere, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067917, JHOC-J9932, JHOC-99061108, NCI-P00-0145 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005878 History of Changes |
Health Authority: | United States: Federal Government |
esophageal cancer |
Anti-Inflammatory Agents Celecoxib Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Cyclooxygenase Inhibitors Esophageal Cancer Digestive System Abnormalities Digestive System Diseases Analgesics, Non-Narcotic Esophageal Disorder |
Barrett Syndrome Head and Neck Neoplasms Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Barrett Esophagus Peripheral Nervous System Agents Analgesics Esophageal Diseases Antirheumatic Agents Congenital Abnormalities |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Therapeutic Uses Barrett Esophagus Anti-Inflammatory Agents, Non-Steroidal Analgesics Celecoxib Digestive System Neoplasms |
Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms Digestive System Diseases Digestive System Abnormalities Analgesics, Non-Narcotic Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |