Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Eflornithine; Sulindac

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