RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer. PURPOSE: Randomized clinical trial to determine the effectiveness of celecoxib in preventing the development of adenomatous polyps in patients who have had at least one polyp removed.

Condition	Treatment or Intervention
prevention of colorectal cancer Colon Cancer Rectal Cancer	Drug: chemoprevention of cancer  Procedure: cancer prevention intervention  Drug: celecoxib

Further Study Details: 

OBJECTIVES: I. Determine the safety and efficacy of celecoxib in reducing the occurrence of new sporadic adenomatous polyps (SAP) in the colon and rectum in patients who have undergone polypectomy for previous SAP.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are entered on one of two treatment arms: Arm I: Patients receive celecoxib twice a day for 3 years. Arm II: Patients receive placebo twice a day for 3 years. Patients are evaluated for adenomatous colorectal polyps at 1 and 3 years.

PROJECTED ACCRUAL: Over 1000 patients will be accrued for this study.

Ages Eligible for Study:  30 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• At least one prior colorectal adenomatous polyp removed by polypectomy within the past 5 months and meeting any of the following criteria: One adenomatous polyp at least 6 cm in size; Two or more adenomatous polyps of any size; One adenomatous polyp and a documented history of adenomatous polyps
• No history of familial polyposis or hereditary nonpolyposis colorectal cancer
• No history of inflammatory bowel disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: At least 2 months since prior oral corticosteroids received 3 or more times per week; At least 6 months since prior oral or intravenous corticosteroids received for more than 2 weeks duration; No anticipated oral or intravenous corticosteroid use of more than 2 weeks duration over the next 6 months; At least 6 months since prior inhaled corticosteroids received for more than 4 weeks duration; No anticipated inhaled corticosteroid use of more than 4 weeks duration over the next 6 months; Use of mometasone (Nasonex) is not restricted (all other nasal steroids are prohibited)
• Radiotherapy: Not specified
• Surgery: No prior large bowel resection other than appendectomy
• Other: At least 1 month since any prior treatment for gastrointestinal ulcer; At least 2 months since prior nonsteroidal anti-inflammatory drugs (NSAIDS), other than aspirin, received 3 or more times per week; No concurrent chronic NSAIDS, defined as a frequency of 1-week (7 consecutive days) for more than 3 weeks per year; At least 1 month since prior investigational medications; No other concurrent investigational drugs; No concurrent fluconazole or lithium

--Patient Characteristics--

• Age: 30 and over
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: No chronic or acute hepatic disorder
• Renal: No chronic or acute renal disorder
• Other: No prior participation in this study; No significant bleeding disorder or other condition that would preclude study therapy; No history of hypersensitivity to COX-2 inhibitors, NSAIDS, salicylates, or sulfonamides; No prior invasive cancer within the past 5 years other than nonmelanomatous skin cancer; Fertile patients must use effective contraception

Alabama
      Medical Affiliated Research Center, Huntsville,  Alabama,  35801,  United States
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States
Arizona
      Urological Associates of Southern Arizona, P.C., Tucson,  Arizona,  85712,  United States
California
      Advanced Clinical Research Institute, Anaheim,  California,  92801,  United States
      California Professional Research, Newport Beach,  California,  92660,  United States
      Capitol Gastroenterology Consultants Medical Group Inc., Carmichael,  California,  95608,  United States
      Gastroenterology Associates of the East Bay Medical Center, Berkeley,  California,  94705,  United States
      Institute for Health Care Assessment, San Diego,  California,  92120,  United States
      Saddleback Memorial Medical Center, Laguna Hills,  California,  92653,  United States
      Western Clinic Research, Inc., Torrance,  California,  90505,  United States
Colorado
      Gastroenterology Associates of Colorado Springs, Colorado Springs,  Colorado,  80907,  United States
Connecticut
      Gastroenterology Associates of Fairfield County, Bridgeport,  Connecticut,  06606,  United States
Florida
      Jupiter Research Association, Jupiter,  Florida,  33458,  United States
      Office of Howard Schwartz, Miami,  Florida,  33173,  United States
      Office of Ira W. Klimberg, Ocala,  Florida,  32674,  United States
Georgia
      Southeastern Digestive and Liver Disease Institute, Savannah,  Georgia,  31404,  United States
Idaho
      Office of Mark Lloyd, Meridian,  Idaho,  83642,  United States
Illinois
      Deerpath Medical Associates, Lake Forest,  Illinois,  60045,  United States
      Glenbrook Hospital, Glenview,  Illinois,  60025,  United States
      North Shore Endoscopy Center, Lake Bluff,  Illinois,  60044,  United States
      Northwest Gastroenterologists, Arlington Heights,  Illinois,  60005,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States
Kansas
      Sun Flower Medical Center, Shawnee Mission,  Kansas,  66204,  United States
Maryland
      Health Trends Research, LLC, Baltimore,  Maryland,  21208,  United States
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Mississippi
      Mississippi Center for Clinical Research, Jackson,  Mississippi,  39216,  United States
New Jersey
      New Jersey Physicians, LLC, Passaic,  New Jersey,  07055,  United States
New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States
      Long Island GI Research Group, Great Neck,  New York,  11023,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Strang Cancer Prevention Center, New York,  New York,  10021,  United States
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States
North Carolina
      Asheville Gastroenterology Associates, Asheville,  North Carolina,  28801,  United States
      C.A.R.E. Center, Raleigh,  North Carolina,  27609,  United States
      Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States
      Charlotte Gastroenterology and Hepatology, Charlotte,  North Carolina,  28207,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Moses Cone Health System, Greensboro,  North Carolina,  27401-1020,  United States
      Wake Research Associates, Incorporated, Raleigh,  North Carolina,  27612,  United States
Ohio
      Gastroenterology Associates of Cleveland, Inc., Mayfield Heights,  Ohio,  44140,  United States
      TQM Research, Cincinnati,  Ohio,  45140,  United States
Oklahoma
      Oklahoma Foundation/Digestive Research, Oklahoma City,  Oklahoma,  73104,  United States
Oregon
      Northwest GI Clinic, Portland,  Oregon,  97210,  United States
      Paul Schleinitz MD and Associates, Medford,  Oregon,  97504,  United States
Pennsylvania
      Allegheny Center for Digestive Health, Pittsburgh,  Pennsylvania,  15212,  United States
      Keystone Digestive Disorders Consultants, Pittsburgh,  Pennsylvania,  15224,  United States
      Regional Gastroenterology Associates of Lancaster, Lancaster,  Pennsylvania,  17604,  United States
      University of Pittsburg Medical Center - Shadyside Hospital, Pittsburgh,  Pennsylvania,  15213-2582,  United States
      Valley Gastroenterology, Beaver Falls,  Pennsylvania,  15010,  United States
Rhode Island
      MultiMed Research, Providence,  Rhode Island,  02906,  United States
Tennessee
      Medical Research Associates of Nashville, Nashville,  Tennessee,  37203,  United States
      Saint Thomas Hospital, Nashville,  Tennessee,  37205,  United States
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
Texas
      GANT Research, PA, Fort Worth,  Texas,  76102,  United States
      Healthcare Discoveries, P.A., San Antonio,  Texas,  78229,  United States
Washington
      Northwest Gastroenterology Associates, Bellevue,  Washington,  98004,  United States
      Olympia Multi-Specialty Clinic, Olympia,  Washington,  98502,  United States
      Spokane Digestive Disease Center, Spokane,  Washington,  99204,  United States
Wisconsin
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53207,  United States
Wyoming
      Veterans Affairs Medical Center - Sheridan, Sheridan,  Wyoming,  82801,  United States
Australia
      Fremantle Hospital, Fremantle,  6160,  Australia
Australia, New South Wales
      Concord Repatriation General Hospital, Concord,  New South Wales,  2139,  Australia
      Sydney Children's Hospital, Randwick,  New South Wales,  2031,  Australia
Australia, Queensland
      Royal Brisbane Hospital, Brisbane,  Queensland,  4029,  Australia
Australia, South Australia
      Flinders Medical Centre, Bedford Park,  South Australia,  5042,  Australia
Australia, Victoria
      Monash Medical Center, Clayton,  Victoria,  3168,  Australia
      Royal Melbourne Hospital, Parkville,  Victoria,  3050,  Australia
      Western Hospital, Melbourne,  Victoria,  3011,  Australia
Australia, Western Australia
      Sir Charles Gairdner Hospital, Perth, Perth,  Western Australia,  6009,  Australia
Canada
      Hamilton Civic Hospital Research Centre, Hamilton,  L8V-IC3,  Canada
Canada, Alberta
      Health Sciences Centre, Calgary,  Alberta,  T2N 4N1,  Canada
      Hys. Medical Ctre., Edmonton,  Alberta,  T5H 4B9,  Canada
Canada, British Columbia
      Vancouver Hospital and Health Sciences Center - BCCA, Vancouver,  British Columbia,  V5Z 1L5,  Canada
Canada, Manitoba
      Health Sciences Centre, Winnipeg,  Manitoba,  R3A 1R9,  Canada
Canada, Nova Scotia
      Queen Elizabeth II Health Science Center, Halifax,  Nova Scotia,  B3H 2Y9,  Canada
Canada, Ontario
      Ottawa Hospital, Ottawa,  Ontario,  K1Y 4E9,  Canada
      Sunnybrook Health Sciences Center, Toronto,  Ontario,  M4X 1W4,  Canada
Canada, Quebec
      Centre Hospital University, Quebec City,  Quebec,  G1L 3L5,  Canada
      Centre Hospitalier de l'Universite' de Montreal, Montreal,  Quebec,  H2W 1T8,  Canada
      Centre Hospitalier Universitaire de Quebec, Quebec City,  Quebec,  G1R 2J6,  Canada
      Hospital Maisooneuve Rosemont, Montreal,  Quebec,  H1T 2M4,  Canada
      Jewish General Hospital - Montreal, Montreal,  Quebec,  H3T 1E2,  Canada
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada
      Royal Victoria Hospital - Montreal, Montreal,  Quebec,  H3A 1A1,  Canada
Canada, Saskatchewan
      St. Paul's Hospital, Saskatoon,  Saskatchewan,  S7K 1N4,  Canada
United Kingdom, England
      South Tees Hospitals NHS Trust, Middlesbrough, Cleveland,  England,  TS4 3BW,  United Kingdom

Study chairs or principal investigators

Monica M. Bertagnolli,  Study Chair,  Brigham and Women's Hospital   

Study ID Numbers:  CDR0000067750; BWH-NO1-CN-95015; NCI-P00-0141; NYH-CMC-0298-108; SC-IQ4-99-02-005; STRANG-98-008
Record last reviewed:  November 2003
Last Updated:  March 24, 2005
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005094
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08