Suspended

Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer

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What is being tested

Celecoxib

+ placebo

DrugOther
Who is being recruted

Colonic Diseases+8

+ Colonic Neoplasms

+ Digestive System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorNSABP Foundation Inc
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Compare celecoxib vs placebo, in terms of decreasing the incidence of adenomatous polyps of the colon and rectum, in patients with resected stage I adenocarcinoma of the colon. Secondary * Compare disease-free survival of patients treated with these regimens. * Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients. * Compare the quality of life of patients treated with these regimens. * Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 (COX-2) with those that do not express COX-2. * Compare the expression of signaling targets such as serine/threonine AKT, extracellular signal-regulated kinase 2 (ERK2), and endoplasmic reticulum Ca+2- ATPases in the index tumor and polyps. * Determine the toxicity and safety of celecoxib in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, tumor stage (T1 vs T2), age (≤ 49 vs 50 to 59 vs ≥ 60 years), and current aspirin use (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral celecoxib twice daily for 3 years. * Arm II: Patients receive oral placebo twice daily for 3 years. In both arms, treatment continues in the absence of unacceptable toxicity or the diagnosis of invasive colon cancer, carcinoma in situ of the colon or rectum, or a non-colon primary cancer. Quality of life is assessed at baseline and then at 6, 12, 24, 36, and 42 months. Patients are followed at 6 months and at 2 years. PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 2.5 years.

Official TitleCelecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer 
NCT00087256
Principal SponsorNSABP Foundation Inc
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteColorectal Neoplasms

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon * Stage I disease * Distal border of tumor ≥ 12 cm from the anal verge * Tumor completely resected within the past 90 days * Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days * All observed polyps must have been removed * Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction * Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible * No prior familial adenomatous polyposis * No prior invasive cancer or carcinoma in situ of the colon or rectum * No clinical or radiologic evidence of metastatic disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * At least 10 years Hematopoietic * Complete blood count normal * Platelet count normal Hepatic * Aspartate aminotransferase (AST) normal * Bilirubin normal * Alkaline phosphatase normal Renal * Creatinine normal Cardiovascular * No active ischemic heart disease * No New York Heart Association class III or IV heart disease * No myocardial infarction within the past 6 months * No symptomatic arrhythmia * No symptomatic peripheral vascular disease or carotid disease that would preclude study participation Pulmonary * No aspirin-sensitive asthma Gastrointestinal * No history of inflammatory bowel disease * No history of upper gastrointestinal bleeding * No history of duodenal or gastric ulcer Other * No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides * No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer * No other disease that would preclude study participation * No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance * No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No other concurrent investigational agents for colon cancer * No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin) * Chronic use is defined as use for more than an average of 3 days per month * Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain * Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed * No concurrent fluconazole or lithium

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
one placebo capsule taken orally twice a day for 3 years

Group II

Experimental
one 400 mg capsule taken orally twice a day for 3 years

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Allegheny General Hospital

Pittsburgh, United StatesSee the location
SuspendedOne Study Center