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Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps conditions. Clinical Trials Search.org is a site committed 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 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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 permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps clinical trial. Participants oftentimes recieve the most expert healthcare available for their Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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 Colon Cancer Studies:
1. Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps

2. Sulindac and Plant Compounds in Preventing Colon Cancer

3. Aspirin and/or Folic Acid in Preventing Recurrent Colorectal Polyps

4. High-Dose Folic Acid in Preventing Colorectal Cancer in Patients Who Have Had Polyps Surgically Removed

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