Status:
COMPLETED
Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Colon Cancer
Precancerous Condition
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased...
Detailed Description
PRIMARY OBJECTIVE: I. Percent change in number of rectal aberrant cryptic foci (ACF) as measured by magnification chromoendoscopy SECONDARY OBJECTIVES: I. Screening for possible phase III testing I...
Eligibility Criteria
Inclusion
- Criteria:
- ECOG performance status 0-2
- Platelet count \>= 100,000/mm\^3
- Fertile patients must agree to use effective contraception
- No history of inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
- No invasive malignancy within the past 5 years except nonmelanoma skin cancer or colorectal cancer
- No history of endoscopically-confirmed peptic ulcer disease
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to the study agents
- No history of chronic liver disease or unexplained persistent elevations of serum transaminases
- No history of allergic-type reactions, including asthma or urticaria, to aspirin or NSAIDs
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude study compliance
- At least 6 weeks since prior oral corticosteroids
- Creatinine =\< 1.5 times ULN
- Creatine phosphokinase =\< 1.5 times ULN
- Not pregnant or nursing
- At least 6 weeks since prior statins
- At increased risk for developing sporadic colorectal neoplasia, as defined by 1 of the following:
- History of colon cancer (excluding stage IV or Dukes' D tumors)
- Must have completed prior adjuvant therapy for colon cancer \>= 12 months ago
- History of colorectal adenomas, meeting any of the following criteria:
- \>= 1 cm in diameter
- \>= 3 in total number
- Any component of villous morphology
- High-grade dysplasia
- At least 5 rectal aberrant cryptic foci (ACF), by magnification chromoendoscopy, meeting both of the following criteria:
- At least 5 aggregated crypts in a single grouping (maximum spacing between crypts must be =\< 2 times the average crypt diameter)
- Crypt diameter \>= 1.5 times the diameter of surrounding normal crypts
- No history of rectal cancer, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer
- Negative pregnancy test
- At least 6 months since prior and no concurrent regular use\* of nonsteroidal anti-inflammatory drugs\*\* (NSAIDs) or statins
- Concurrent aspirin at cardioprotective doses (=\< 162.5 mg/day or 325 mg every other day) allowed
- No prior rectal surgery involving mucosal resection
- No prior pelvic radiation therapy
- No concurrent regular use\* of cyclooxygenase-2 inhibitors
- No concurrent anticoagulant drugs (i.e., warfarin, heparin, clopidogrel bisulfate, or extended-release dipyridamole)
- No concurrent use of any of the following:
- Fibrates (e.g., gemfibrozil or fenofibrate)
- Cyclosporine
- Erythromycin or macrolide antibiotics
- Protease inhibitors
- Azole antifungals
- Diltiazem
- Verapamil
- Compounds containing niacin or nicotinic acid
- Defined as 7 consecutive days for \> 3 weeks OR \> 21 days total during study participation
- Patients may be eligible for study treatment after discontinuing NSAIDs for 12 weeks, at the discretion of their health care provider
- No other concurrent investigational agents
- No planned (or likely to require) clinically indicated colonoscopy or flexible sigmoidoscopy during study treatment
- Bilirubin =\< 1.5 times ULN
- Hemoglobin \>= lower limit of normal
- AST =\< 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase =\< 1.5 times ULN
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00335504
Start Date
March 1 2006
End Date
April 1 2009
Last Update
February 15 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905