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

• Status: Completed
• Trial end date: 2006-04-21
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

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