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Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps Clinical research trials and Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps. Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps  Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
For Condition: Colon Cancer,prevention of colorectal cancer,Rectal Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Brigham and Women's Hospital
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 30 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MonicaBertagnolli, Study Chair, Brigham and Women's Hospital
New Jersey Physicians, LLC
Passaic, New Jersey, 07055
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Strang Cancer Prevention Center
New York City, New York, 10021
United States
Gastroenterology Associates of Colorado Springs
Colorado Springs, Colorado, 80907
United States
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1
Canada
Northwest Gastroenterology Associates
Bellevue, Washington, 98004
United States
Moses Cone Health System
Greensboro, North Carolina, 27401-1020
United States
Vancouver Hospital and Health Sciences Center - BCCA
Vancouver, British Columbia, V5Z 1L5
Canada
Long Island GI Research Group
Great Neck, New York, 11023
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Western Clinic Research, Inc.
Torrance, California, 90505
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Health Sciences Centre
Calgary, Alberta, T2N 4N1
Canada
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, B3H 2Y9
Canada
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Saint Thomas Hospital
Nashville, Tennessee, 37205
United States
Oklahoma Foundation/Digestive Research
Oklahoma City, Oklahoma, 73104
United States
North Shore Endoscopy Center
Lake Bluff, Illinois, 60044
United States
Valley Gastroenterology
Beaver Falls, Pennsylvania, 15010
United States
TQM Research
Cincinnati, Ohio, 45140
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Royal Brisbane Hospital
Brisbane, Queensland, 4029
Australia
Capitol Gastroenterology Consultants Medical Group Inc.
Carmichael, California, 95608
United States
Hamilton Civic Hospital Research Centre
Hamilton, , L8V-IC3
Canada
Northwest GI Clinic
Portland, Oregon, 97210
United States
Veterans Affairs Medical Center - Sheridan
Sheridan, Wyoming, 82801
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
Office of Ira W. Klimberg
Ocala, Florida, 32674
United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Australia
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Sunnybrook Health Sciences Center
Toronto, Ontario, M4X 1W4
Canada
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Canada
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, 85712
United States
Jupiter Research Association
Jupiter, Florida, 33458
United States
Health Trends Research, LLC
Baltimore, Maryland, 21208
United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606
United States
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Medical Research Associates of Nashville
Nashville, Tennessee, 37203
United States
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, H2W 1T8
Canada
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Paul Schleinitz MD and Associates
Medforo, Oregon, 97504
United States
Hys. Medical Ctre.
Edmonton, Alberta, T5H 4B9
Canada
Institute for Health Care Assessment
San Diego, California, 92120
United States
Office of Howard Schwartz
Miami, Florida, 33173
United States
Centre Hospital University
Quebec City, Quebec, G1L 3L5
Canada
Medical Affiliated Research Center
Huntsville, Alabama, 35801
United States
Wake Research Associates, Incorporated
Raleigh, North Carolina, 27612
United States
Spokane Digestive Disease Center
Spokane, Washington, 99204
United States
Keystone Digestive Disorders Consultants
Pittsburgh, Pennsylvania, 15224
United States
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
United Kingdom
GANT Research, PA
Ft. Worth, Texas, 76102
United States
Mississippi Center for Clinical Research
Jackson, Mississippi, 39216
United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
United States
Northwest Gastroenterologists
Arlington Heights, Illinois, 60005
United States
California Professional Research
Newport Beach, California, 92660
United States
Fremantle Hospital
Fremantle, , 6160
Australia
Gastroenterology Associates of the East Bay Medical Center
Berkeley, California, 94705
United States
University of Pittsburg Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, 15213-2582
United States
Sydney Children's Hospital
Randwick, New South Wales, 2031
Australia
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207
United States
Glenbrook Hospital
Glenview, Illinois, 60025
United States
Southeastern Digestive and Liver Disease Institute
Savannah, Georgia, 31404
United States
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17604
United States
St. Paul's Hospital
Saskatoon, Saskatchewan, S7K 1N4
Canada
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Advanced Clinical Research Institute
Anaheim, California, 92801
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
MultiMed Research
Providence, Rhode Island, 02906
United States
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2
Canada
Royal Melbourne Hospital
Parkville, Victoria, 3050
Australia
Sun Flower Medical Center
Shawnee Mission, Kansas, 66204
United States
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, 6009
Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042
Australia
Healthcare Discoveries, P.A.
San Antonio, Texas, 78229
United States
Olympia Multi-Specialty Clinic
Olympia, Washington, 98502
United States
Gastroenterology Associates of Cleveland, Inc.
Mayfield Heights, Ohio, 44140
United States
C.A.R.E. Center
Raleigh, North Carolina, 27609
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Western Hospital
Melbourne, Victoria, 3011
Australia
Monash Medical Center
Clayton, Victoria, 3168
Australia
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
United States
Deerpath Medical Associates
Lake Forest, Illinois, 60045
United States
Hospital Maisooneuve Rosemont
Montreal, Quebec, H1T 2M4
Canada
Office of Mark Lloyd
Meridian, Idaho, 83642
United States
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Canada
Additional Information:
Study ID Numbers: CDR0000067750; BWH-NO1-CN-95015,NCI-P00-0141,NYH-CMC-0298-108,SC-IQ4-99-02-005,STRANG-98-008
Study Start Date: March 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005094
Other Prevention Of Colorectal Cancer Studies:
1. Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
2. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
3. Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Colorectal Cancer
4. Curcumin for the Prevention of Colon Cancer
5. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer
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Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
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