Clinical trial · Interventional
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
NCT00087256CI-TRIAL-00008807terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): For scientific, logistic, and administrative reasons.
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known whether celecoxib is effective in preventing polyps in patients with colon cancer. PURPOSE: Randomized phase III trial to study the effectiveness of celecoxib in preventing the development of polyps in patients who have undergone surgery for stage I colon cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm 1: placebo
- description
- one placebo capsule taken orally twice a day for 3 years
- interventionNames
- Drug: Celecoxib
- type
- EXPERIMENTAL
- label
- Arm 2: celecoxib
- description
- one 400 mg capsule taken orally twice a day for 3 years
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- To determine whether celecoxib 400 mg bid for 3 years will decrease the incidence of adenomatous polyps of the colon and rectum in participants with Stage I adenocarcinoma of the colon.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 lithiumReferences
Publications (0)
Data not yet available
No reference posted for this study.