Status:
COMPLETED
Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Precancerous Condition
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 ...
Detailed 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. Correl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00118365
Start Date
July 1 1998
End Date
August 1 2008
Last Update
January 22 2015
Active Locations (1)
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1
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868