Clinical trial · Interventional
Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia
Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib
NCT00043043CI-TRIAL-00010826completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.