Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis

DISEASE CHARACTERISTICS:

Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing

Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation)

No attenuated FAP genotype, defined by any of the following:

Mutation at the 5' end of APC and exon 4
Exon 9-associated phenotypes
3' region mutations

Has an intact colon

No requirement for colectomy
Parent(s) do not desire colectomy (regardless of adenoma burden)

Colorectal adenoma burden as assessed by baseline colonoscopy

No diagnosis of severe dysplasia or greater
No more than 10 adenomas ≥ 1 cm
No more than 100 adenomas of any size
No evidence of anemia (hematocrit < 33%)
No new diagnosis of carcinoma

PATIENT CHARACTERISTICS:

White Blood Count (WBC) > 3,000/μL
Platelet count > 100,000/μL
Hemoglobin > 10.0 g/dL
Aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 1.5 times upper limit of normal (ULN)
Alkaline phosphatase < 1.5 times ULN
Total bilirubin < 1.5 times ULN
Creatinine < 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
No history of peptic ulcer disease
No significant medical or psychiatric problem that, in the opinion of the principal investigator, would make the patient a poor candidate for the study
No other unacceptable clinical risk (e.g., previously unknown bleeding diatheses)
No invasive carcinoma within the past 5 years

PRIOR CONCURRENT THERAPY:

More than 3 months since prior investigational agent
More than 6 months since prior chemotherapy
No prior radiotherapy to the pelvis
At least 3 months since prior NSAIDs (at any dose) at a frequency of ≥ 3 times/week
At least 1 month since prior NSAIDs (at any dose) at a frequency of < 3 times/week
At least 1 month since prior nasal steroids
Concurrent Nonsteroidal Antiinflammatory Drugs (NSAIDs) allowed provided they are administered ≤ 5 times per month
Concurrent orally inhaled steroids allowed provided they are administered for ≤ 4 weeks over a 6-month period
Concurrent oral or intravenous (IV) corticosteroids allowed provided they are administered for ≤ 2 consecutive weeks over a 6-month period
Concurrent proton pump inhibitors to treat gastric reflux allowed
No concurrent nasal steroids except mometasone (Nasonex)
No concurrent fluconazole, lithium, or adrenocorticosteroids