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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer