Colon Cancer Clinical Trial
Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
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
Full Description
PRIMARY OBJECTIVES:
I. Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.
II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.
III. Compare the rate of side effects in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).
Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral double placebo once daily.
Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.
In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
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
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There is 1 Location for this study
Orange California, 92868, United States
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