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

Completed · Phase 2 · Has a placebo group

Conditions studied: Colorectal Cancer, Familial Adenomatous Polyposis

In brief

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.

Key facts

Study ID: NCT00033371
Run by: National Cancer Institute (NCI)
People needed: 205
Starts: 2001-12-13
Expected to finish: 2009-03-24
Last updated by the study team: 2020-09-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

REGISTRATION INCLUSION CRITERIA:
Diagnosis of FAP based on any of the following will be acceptable:
> 100 polyps or
> 10 polyps and age < 40 years, or > 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

You may not qualify if…

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 candidate
Use of any investigational agent within the last 3 months, or at the discretion of the medical monitor
History of pelvic radiation
RANDOMIZATION EXCLUSION CRITERIA:
Anticipated colectomy within eight months of randomization; the results of the initial endoscopies, including pathology reports and blood tests will be reviewed by the study endoscopist and surgeon prior to initiation of drug treatment to determine if the patient can remain on study
Discrete gastric or duodenal ulcer of size > 5 mm; patients with Helicobacter pylori related peptic ulcers of > 5 mm at the time of the baseline endoscopy will become eligible upon endoscopically documented successful treatment of Helicobacter pylori and of the ulcer(s).
Hemoglobin (Hgb) < 10.0 gm/dl
Platelet count < 100,000/ml
White blood cell (WBC) with differential < 3,000/ml
Serum glutamate pyruvate transaminase (SGPT) > 1.5 x upper limit of normal, serum glutamic oxaloacetic transaminase (SGOT) > 1.5 upper limit of normal
Alkaline phosphatase > 1.5 x upper limit of normal
Bilirubin > 2 x upper limit of normal
Creatinine > 1.5 x upper limit of normal
Has had a positive serum pregnancy test within 14 days prior to baseline randomization
Known or prior coagulopathy
Elevated C-reactive protein (CRP) (> 3.0 mg/L)

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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