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	Treatment or Intervention
prevention of esophageal cancer Esophageal Cancer	Drug: celecoxib  Drug: selenium

Further Study Details: 

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.

PROTOCOL 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 at 6 months.

PROJECTED ACCRUAL: A total of 240-600 patients (60-150 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  40 Years   -   69 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed esophageal squamous dysplasia; Endoscopically visible lesion of mild or moderate grade
• No symptoms of upper GI malignancy (e.g., dysphagia, odynophagia, hematemesis, or weight loss of greater than 10% body weight in past 6 months)

--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

--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

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
Maryland
      Cancer Prevention Studies Branch, Bethesda,  Maryland,  20892,  United States
New York
      University of Rochester, Rochester,  New York,  14627,  United States
China
      Cancer Institute Hospital, Chinese Academy of Medical Sciences, Beijing,  100021,  China

Study chairs or principal investigators

Sanford M. Dawsey,  Study Chair,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000067930; NCI-OH95-C-N026; NCI-P00-0157
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005885
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08