Clinical Trials Search
Clinical Trial 19205
Interventions:Placebo; eflornithine; sulindac
Study Type: Treatment
Phase of Study: Phase III
- Mokenge Malafa
Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III-Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)
The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.
1.1 Primary Objective(s): a. To assess whether the combination of eflornithine and sulindac is effective in reducing the three-year event rate (high-risk adenomas and second primary colorectal cancers) in patients with previously treated Stage 0-III colon or rectal cancer. 1.2 Secondary Objective(s): a. To assess whether the combination of eflornithine and sulindac (compared to corresponding placebos) has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas greater than or equal to 0.3cm, total advanced colorectal events, or total colorectal events. b. To assess quantitative and qualitative toxicities of patients when treated with the combination of eflornithine and sulindac compared to corresponding placebos. c. To evaluate a minimal set of tagging single nucleotide polymorphisms across multiple genes relevant to eflornithine and sulindac, in order to characterize associations with decreased adenoma/second primary colorectal (CRC) risk and adverse events. d. To evaluate biomarker responses of treatment effect using novel microfluidics-based digital droplet detection system. e. To explore the interaction of intervention arm and baseline statin use with respect to the 3-year event rate. f. To explore the interaction of the intervention arm and patient-reported meat consumption with respect to the 3-year event rate. g. To perform population pharmacokinetic (PK) analysis of eflornithine and sulindac in patients with previously treated Stage 0-III colon or rectal cancer. (Sites participating in PK sampling are listed on page 1a of the protocol).