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Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00043043
First received: August 5, 2002
Last updated: December 13, 2008
Last verified: November 2004
History of Changes
  Purpose

RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.


Condition Intervention Phase
Colorectal Cancer
 Drug: celecoxib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib

Resource links provided by NLM:

Drug Information available for: Celecoxib
U.S. FDA Resources

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

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

Primary

  • Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia.

Secondary

  • Compare the effects of these drugs on proliferation index, apoptotic index, and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment.
  • Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening, surveillance, or diagnostic colonoscopy.

OUTLINE: This is a randomized, double-blind, placebo-controlled, chemoprevention study. Patients are stratified according to age (18 to 49 vs 50 and over) and number of rectal aberrant crypt foci (5-9 vs 10 or more).

All patients undergo a baseline biomarker assessment and full colonoscopy to resect all neoplasms, quantitate rectal aberrant crypt foci, and biopsy rectal mucosa.

Depending on the results of the biomarker assessments, patients are randomized to 1 of 2 treatment arms. Patients with no adenomas of 5 mm or greater receive no further treatment.

  • Arm I: Patients receive oral celecoxib twice daily.
  • Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.

All patients undergo an endoscopic exam of the colorectum at completion of study.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for the baseline biomarker assessment and a total of 40 patients (20 per arm) will be accrued for the chemoprevention study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Age 18 to 49 with one of the following colorectal abnormalities:

    • At least one adenoma that is at least 1 cm
    • At least 3 adenomas of any size with at least 5 rectal aberrant crypt foci (ACFs)

  • Age 50 and over with one of the following colorectal abnormalities:

    • At least one adenoma that is at least 5 mm and at least 5 rectal ACFs
    • History of polyps (at least 1 adenoma) within the past 5 years
  • No history of germline cancer syndrome
  • No stage III or IV colorectal cancer (Dukes' C or D) diagnosed within the past 6 months
  • No current colorectal cancer
  • No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)

PATIENT CHARACTERISTICS:

Age

  • See Disease Characteristics
  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin greater than 11.5 g/dL
  • WBC greater than 3,000/mm^3
  • Platelet count greater than 125,000/mm^3
  • No significant bleeding disorder

Hepatic

  • AST and ALT no greater than 1.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 1.5 times ULN
  • No chronic or acute hepatic disorder

Renal

  • Creatinine no greater than 1.5 times ULN
  • No chronic or acute renal disorder

Cardiovascular

  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure

Pulmonary

  • No asthma
  • No severe chronic obstructive pulmonary disease

Gastrointestinal

  • No active gastrointestinal ulcers
  • No history of peptic ulcer disease

Other

  • No prior hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs
  • No medical contraindication to NSAID use
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective contraception
  • No known allergic reaction to indigo carmine
  • No other clinically significant medical condition or abnormal laboratory value that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Anticipated use of corticosteroids less than 2 weeks over 6 months

  • Anticipated use of mometasone less than 4 weeks over 6 months

    • No other concurrent inhaled steroids for 30 days before or during study participation

Radiotherapy

  • No prior pelvic radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational drugs
  • No prior participation in this study
  • No regular nonsteroidal anti-inflammatory drug (NSAID) or aspirin use (average of 3 or more doses per week for at least 3 months) except low-dose aspirin for cardiovascular disease prophylaxis
  • No other concurrent investigational drugs
  • No concurrent fluconazole or lithium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043043

Locations
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5600
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Ernest Hawk National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00043043     History of Changes
Obsolete Identifiers: NCT00056615
Other Study ID Numbers: CDR0000069498, NCI-02-C-0194
Study First Received: August 5, 2002
Last Updated: December 13, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colorectal cancer

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 17, 2013