At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of FAP based on >100 polyps OR >10 polyps with age <40 years OR >25 polyps with age >40 years and characteristic family history OR genetic diagnosis by IVSP or similar assay
- ✓Endoscopically assessable colonic and/or rectal segment at registration
- ✓After baseline endoscopy, must have ≥5 polyps ≥2 mm diameter in rectum OR ≥5 polyps ≥2 mm diameter in colon (including ≥3 quantifiable polyps >3 mm OR ≥2 quantifiable polyps >5 mm)
- ✓Willingness to abstain from NSAIDs including aspirin for duration of study; cardio-protective aspirin ≥80 mg may be permitted with PI approval
- ✕Anticipated colectomy within 8 months of randomization
- ✕History of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs or salicylates
- ✕Chronic NSAID/aspirin use in prior 6 months requires 3-month washout; must be off all NSAIDs for 3 months prior to enrollment
- ✕Use of fluconazole, lithium, or chronic adrenocorticosteroids
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Arm Phase II Chemoprevention Trial in Adenomatous Polyposis Coli Patients
In Brief
A Phase 2 clinical trial evaluating Celecoxib, Placebo, and 3 other interventions for Colorectal Cancer and Familial Adenomatous Polyposis. Completed, enrolled 205 participants across 1 site.
Detailed Summary
This randomized phase II trial studies how well giving celecoxib with or without eflornithine works in preventing colorectal cancer in patients with familial adenomatous polyposis. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib and eflornithine may keep cancer from forming in patients with familial adenomatous polyposis.
Study Details
Timeline
Interventions
Given 400 mg PO twice a day
Given PO to match DFMO
Given PO at 0.5 gm/m\^2/day rounded down to the nearest 250 mg dose (BSA of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day).
Correlative studies
Ancillary studies