S0820, Adenoma and Second Primary Prevention Trial (PACES)

What is the purpose of this trial?

Primary Objective

  1. To assess whether eflornithine (+/- sulindac), sulindac (+/- eflornithine) or the combination are 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 cancer.

Secondary Objectives

  1. To assess whether eflornithine, sulindac or the combination has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, adenomas 1 cm or greater, multiple adenomas, any adenomas ≥ 0.3 cm, total advanced colorectal events, or total colorectal events.
  2. To assess quantitative and qualitative toxicities of patients when treated with eflornithine, sulindac, or the combination compared to placebo.
  3. 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 cancer (CRC) risk and adverse events.
  4. To examine the interaction of intervention arm and baseline statin use with respect to the 3-year event rate.
  5. To examine the interaction of the intervention arm and patient-reported meat consumption with respect to the 3-year event rate.
  6. (Arizona Cancer Center, M.D. Anderson Cancer Center, UC Irvine Medical Center and Wichita CCOP ONLY) To perform population pharmacokinetic (PK) analysis of eflornithine and sulindac in patients with previously treated Stage 0-III colon cancer.

Participation Guidelines

Ages: 18 years and older

Gender: Both

Southwest Oncology Group (SWOG)

Start Date: 03/23/2016

End Date: 06/30/2024

Last Updated: 02/22/2018

Study HIC#: 1402013375