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