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Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: April 18, 2009   History of Changes
Sponsors and Collaborators: Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005094
  Purpose

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: This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.


Condition Intervention Phase
Colorectal Cancer
Drug: celecoxib
Phase III

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Celecoxib
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: Prevention of Sporadic Colorectal Adenomas With Celecoxib (APC)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

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.

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005094

  Show 92 Study Locations
Sponsors and Collaborators
Dana-Farber/Brigham and Women's Cancer Center
Investigators
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067750, BWH-NO1-CN-95015, NYH-CMC-0298-108, SC-IQ4-99-02-005, STRANG-98-008, NCI-P00-0141
Study First Received: April 6, 2000
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00005094     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Study placed in the following topic categories:
Anti-Inflammatory Agents
Celecoxib
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Cyclooxygenase Inhibitors
Colonic Diseases
Rectal Neoplasm
Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Adenoma
Colorectal Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Rectal Diseases
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Celecoxib
Digestive System Neoplasms
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009