Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00043043

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
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:

MedlinePlus related topics: Cancer Colorectal Cancer

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

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

Keywords provided by National Cancer Institute (NCI):

colorectal cancer

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 November 05, 2009