Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
Condition: Precancerous Condition
MeSH terms: Precancerous Conditions
Intervention: placebo; eflornithine; sulindac; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Given orally; Correlative studies
Intervention MeSH terms: Eflornithine; Sulindac
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 375.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying eflornithine and sulindac to see how well they
      work compared to a placebo in preventing colorectal cancer in patients with colon polyps.
      Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming
      back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known
      whether eflornithine and sulindac are more effective than a placebo in preventing colorectal
      cancer
    

Eligibility criteria:

        Criteria:

          -  History of >= 1 surgically resected adenomatous polyp of the colon measuring >= 3 mm
             within the past 5 years

          -  Screening colonoscopy performed within the past 6 months

          -  All polyps must have been removed during colonoscopy, pathologically examined, and
             archived

          -  No prior surgical resection removing > 40 cm of the colon

          -  No personal or family history of familial polyposis or hereditary non-polyposis colon
             cancer

          -  SWOG 0-1

          -  Bilirubin =< 2.0 mg/dL

          -  AST and ALT =< 2 times normal

          -  Creatinine =< 1.5 mg/dL

          -  Urine protein =<, urine casts 0-3, urine WBC and RBC count 0-5 cells by urinalysis

          -  No history of inflammatory bowel disease

          -  No gastric or duodenal ulcers within the past 12 months

          -  Gastric or duodenal ulcers that were adequately treated > 24 months ago are allowed

          -  No symptomatic gastric or duodenal ulcers

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Must have regional geographic stability over the next 36 months

          -  Pure tone audiometry evaluation normal

          -  Patients with >= 20 dB of uncorrectable hearing loss (for age) of any 2 contiguous
             frequencies are not allowed

          -  No invasive malignancy within the past 5 years except adequately treated nonmelanoma
             skin cancer, level I (or Breslow < 0.76 mm) cutaneous melanoma, Duke's A colon cancer,
             stage I cervical cancer, or stage 0 chronic lymphocytic leukemia

          -  No severe metabolic disorder

          -  No other significant acute or chronic disease that would preclude study participation

          -  No history of abnormal wound healing or repair

          -  No conditions that would confer risk of abnormal wound healing or repair

          -  No history of allergy to NSAIDs or eflornithine

          -  No concurrent chemotherapy

          -  No concurrent corticosteroids on a regular or predictable intermittent basis

          -  No concurrent radiotherapy

          -  Concurrent calcium supplements (=< 1,000 mg/day) allowed

          -  Concurrent lipid-lowering drugs (i.e., high-dose statins) allowed

          -  No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular or
             predictable intermittent basis

          -  Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 mg/day) allowed

          -  No concurrent anticoagulants on a regular or predictable intermittent basis

          -  No concurrent treatment for gastric or duodenal ulcers