Status:
COMPLETED
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Precancerous Condition
Eligibility:
All Genders
10-14 years
Phase:
PHASE1
Brief 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 polypo...
Detailed Description
OBJECTIVES: Primary * Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis. Secondary * Determine the aberrant crypt foci (ACF...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 21 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00685568
Start Date
November 21 2002
End Date
April 21 2006
Last Update
November 7 2018
Active Locations (4)
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1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
2
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
3
Texas Children's Hospital
Houston, Texas, United States, 77030
4
University of Texas Medical School at Houston
Houston, Texas, United States, 77030