Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

Inclusion Criteria

• REGISTRATION INCLUSION CRITERIA:
• Diagnosis of FAP based on any of the following will be acceptable:
• > 100 polyps or
• > 10 polyps and age 25 polyps and age > 40 years and characteristic family history (autosomal dominant pattern) including:
• > 100 polyps in a first degree family member or
• > 25 polyps in two relatives in two generations, including a first degree family member or
• Genetic diagnosis in a relative or
• Genetic diagnosis by in vitro synthesized protein (IVSP) or similar assay
• Willingness to abstain from use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, for the duration of the study; a cardio-protective dose of aspirin (>= 80 mg) may be permitted but must be reviewed/approved by principal investigator (PI)
• If participant is female and of child bearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception (e.g. abstinence, condom, intrauterine device [IUD], birth control pill, diaphragm and spermicide gel combination) since her last menses and will use adequate contraception during the study, is not lactating, and agrees to undergo a serum pregnancy test at baseline, month 3 and month 6; sexually active males must agree to use an accepted and effective method of contraception
• Colon polyp status: the participant has an endoscopically assessable colonic and/or rectal segment
• Participant has no clinically significant hearing loss that is defined by the patient reporting that their hearing loss affects their everyday life and/or wears a hearing aide
• Participants whose air conduction pure tone audiogram reveals a deficit that differs from the age specific norm by less than 30 dB when averaged across two contiguous test frequencies in either ear are eligible, as long as no self-reported hearing deficit or tinnitus is present
• Willingness and ability to sign informed consent
• RANDOMIZATION INCLUSION CRITERIA:
• The individual has assessable colonic polyps remaining in the colon or rectum post baseline colonoscopy or flexible sigmoidoscopy
• Potential participants must have the following colonic or rectal polyp burden at the conclusion of the baseline endoscopy:
• Rectum:
• Five or more polyps >= 2 mm diameter
• Colon:
• Five or more polyps >= 2 mm diameter including:
• Three quantifiable polyps > 3 mm diameter, or two quantifiable polyps > 5 mm diameter
• In the colon, quantifiable polyps are defined as being within a composite "cloverleaf" photograph that includes a tattoo, the appendix, or the ileocecal valve

Exclusion Criteria

• REGISTRATION EXCLUSION CRITERIA:
• Anticipated colectomy within eight months of randomization
• History of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs or salicylates
• Chronic use of NSAIDs, including aspirin or Celebrex, at any dose during the six months prior to study entry will require a three-month washout period prior to eligibility beginning with the time of the patient's last dose; participants must voluntarily agree to be off all NSAIDs for three months prior to study enrollment; a cardio-protective dose of aspirin (>= 80 mg) may be permitted but must be reviewed/approved by PI
• The use of fluconazole, lithium or chronic use of adrenocorticosteroids
• History in the past year of discrete gastric or duodenal ulcer of size > 5 mm, except that those with a history of Helicobacter pylori related peptic ulcer disease will become eligible for study upon successfully completing antibiotic treatment of Helicobacter pylori
• History of invasive carcinoma in the past five years other than resected Duke's A/B1 colon cancer or resected non-melanomatous skin cancer
• Partial or complete colectomy within 12 months prior to enrollment
• Inability to return for follow-up tests
• Significant medical or psychiatric problems, (including significant renal, hepatic or hematologic dysfunction) which would make the individual a poor protocol candida