SWOG S0820/PACES (Preventing Adenomas of the Colon with Eflornithine and Sulindac): A randomized, double-blind, placebo-controlled phase III clinical trial.

Abstract

TPS3627 Background: After standard treatment for stage 0-III colorectal cancer (CRC), patients remain at increased risk for metachronous high-risk adenomas (HRAs) and 2ndprimary CRCs. Polyamines, in excess, are implicated in CRC carcinogenesis. In prior CRC chemoprevention clinical trials, low doses of polyamine-inhibitory agents eflornithine (E) and sulindac (S) demonstrated impressive efficacy. In the prior phase III clinical trial of colorectal adenoma (CRA) patients the combination E+S vs. placebo for 3-years resulted in > 92% reduction in risk of HRAs. Utility of these agents in colon cancer survivors, however, is unknown. Methods: Eligibility:Patients age > 18 with colon or rectosigmoid adenocarcinoma, stage 0, I, II, or III are eligible. Patients with major cardiovascular risk factors (MI, CVA) are excluded, as are patients with hearing loss > 30dB at 4K Hz and below. Daily low dose aspirin is allowed. Study Design: Patients are enrolled 9-15 months postoperatively for a 3-year duration in the rand...