Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Closed 30 and over NCI BWH-NO1-CN-95015 NYH-CMC-0298-108, SC-IQ4-99-02-005, STRANG-98-008, NCI-P00-0141, NCT00005094

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.

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

Expected Enrollment

Over 1000 patients will be accrued for this study.

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.

Bertagnoli MM, Eagle CJ, Hawk ET: Celecoxib reduces sporadic colorectal adenomas: results from the Adenoma Prevention with Celecoxib (APC) trial. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. A-CP-3, 2006.

Bertagnolli MM, Eagle CJ, Zauber AG, et al.: Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 355 (9): 873-84, 2006.[PUBMED Abstract]

Solomon SD, Pfeffer MA, McMurray JJ, et al.: Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation 114 (10): 1028-35, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Brigham and Women's Cancer Center

Monica M. Bertagnolli, MD, Protocol chair		Ph: 617-732-8910; 800-638-6294

Registry Information
Official Title		Prevention of Sporadic Colorectal Adenomas with Celecoxib (APC)
Trial Start Date		2000-03-07
Registered in ClinicalTrials.gov		NCT00005094
Date Submitted to PDQ		2000-03-07
Information Last Verified		2007-06-12