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