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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005885 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. The use of selenium and celecoxib may be an effective way to prevent esophageal cancer in patients with esophageal dysplasia.
PURPOSE: Randomized clinical trial to determine the effectiveness of selenium and celecoxib, alone or in combination, in preventing cancer in patients who have esophageal dysplasia.
| Condition | Intervention |
|---|---|
|
Esophageal Cancer |
Dietary Supplement: selenium Drug: celecoxib |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized |
| Official Title: | A Pilot Study of Selenomethionine and Celecoxib as Chemopreventive Agents for Esophageal Squamous Dysplasia in Linxian, China |
| Study Start Date: | May 2000 |
OBJECTIVES: I. Determine the effectiveness (regression of disease) of selenium and celecoxib, alone or in combination, in patients with esophageal squamous dysplasia who are residing in Linxian, People's Republic of China.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified according to grade of histologic dysplasia (mild versus moderate) and gender. Patients are randomized to one of four treatment arms. Arm I: Patients receive oral selenium once daily and oral celecoxib twice daily. Arm II: Patients receive oral selenium once daily and an oral placebo twice daily. Arm III: Patients receive an oral placebo once daily and oral celecoxib twice daily. Arm IV: Patients receive an oral placebo once daily and a second oral placebo twice daily. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 240-600 patients (60-150 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 40 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous dysplasia of mild or moderate grade Endoscopically visible lesion No symptoms of upper GI malignancy (e.g., dysphagia, odynophagia, hematemesis, or weight loss of greater than 10% body weight in past 6 months)
PATIENT CHARACTERISTICS: Age: 40 to 69 at time of screening Performance status: Not specified Life expectancy: Not specified Hematopoietic: No bleeding disorder Hepatic: Not specified Renal: No kidney disease Cardiovascular: No uncontrolled congestive heart failure or unstable angina Pulmonary: No severe pulmonary disease No asthma Other: Resident of Linxian, Henan Province, People's Republic of China Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious illness that would preclude study No other concurrent malignancy except nonmelanoma skin cancer No peptic ulcer disease No known allergy to lidocaine, iodine, selenium, sulfa drugs, or celecoxib
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent corticosteroids Radiotherapy:
Not specified Surgery: Not specified Other: No concurrent aspirin or other nonsteroidal antiinflammatory drugs
Contacts and Locations| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Maryland | |
| Cancer Prevention Studies Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14627 | |
| China | |
| Cancer Institute Hospital, Chinese Academy of Medical Sciences | |
| Beijing, China, 100021 | |
| Study Chair: | Sanford M. Dawsey, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000067930, NCI-OH95-C-N026, NCI-P00-0157 |
| Study First Received: | June 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005885 History of Changes |
| Health Authority: | United States: Federal Government |
|
esophageal cancer |
|
Anti-Inflammatory Agents Antioxidants Digestive System Neoplasms Celecoxib Gastrointestinal Diseases Esophageal Neoplasms Cyclooxygenase Inhibitors Esophageal Cancer Trace Elements Selenium Digestive System Diseases |
Analgesics, Non-Narcotic Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Esophageal Diseases Micronutrients Antirheumatic Agents |
|
Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Selenium Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Micronutrients Analgesics Celecoxib Digestive System Neoplasms |
Growth Substances Cyclooxygenase Inhibitors Trace Elements Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Head and Neck Neoplasms Gastrointestinal Neoplasms Peripheral Nervous System Agents Esophageal Diseases Antirheumatic Agents Central Nervous System Agents |
