Treatment trial testing for reduced recurrence of certain colorectal cancers

Study ID: S0820

A 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 0-3 colon or rectal cancer. Phase 3: preventing adenomas of the colon with eflornithine and sulindac (PACES)

In this study researchers seek to determine if a treatment combination will be effective in reducing the three-year rate of adenomas and second primary colorectal cancers in patients previously treated for stages 0 through 3 colon cancer. The drugs being tested include eflornithine and sulindac.

Patients will be randomized into treatment arms for this 36-month clinical trial:

  • Eflornithine and sulindac placebo
  • Eflornithine placebo and sulindac
  • Eflornithine and sulindac
  • Two placebos

Inclusion criteria:

  • Stage 0-III colon or rectal cancer with primary resection 1 year previously
  • Post-op colonoscopy and CT scans of chest, abdomen and pelvis showing NED
  • No cardiovascular risk factors, including unstable angina, hx of MI, or CVA, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure
  • No known uncontrolled hyperlipidemia within 28 days prior to registration
  • Must be 30 days from completion of adjuvant chemotherapy and radiation therapy
  • Controlled gastroesophageal reflux disease acceptable
  • No concomitant corticosteroids, NSAIDs or anticoagulants
  • Maximum aspirin dose 100 mg/day or ≤ two 325 mg tablets/week

Additional schema information (PDF)

Inclusion Snapshot

  • Must have been diagnosed with stage 0-3 colon or rectal cancer with primary resection one year previously
  • Must have no cardiovascular risk factors

Contact Information

Lankenau Institute for Medical Research trial