Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients With Benign Colorectal Polyps

Colorectal Cancer Clinical Trial

Official title: A Phase II Clinical Trial of a Randomized, Double-Blind, Placebo Controlled Clinical Trial of DFMO and Sulindac Against Various Endpoints of Colorectal Pathobiology in a Cohort of Individuals at Increased Risk of Colorectal Carcinoma

Status Completed

Clinical Trial Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine and sulindac may be an effective way to prevent the development of colorectal cancer in patients who have had surgery to remove benign colorectal polyps.

PURPOSE: Randomized, double-blinded, phase II trial to determine the effectiveness of eflornithine plus sulindac compared to a placebo in preventing colorectal cancer in patients who have had surgery to remove benign colorectal polyps.

Clinical Trial Description

OBJECTIVES:

• Compare the efficacy of eflornithine (DFMO) and sulindac vs placebo in modulating a panel of surrogate endpoint biomarkers (SEB) of particular relevance in colorectal neoplasia, including quantitative histopathology, uninduced apoptosis, proliferative (Ki67) and preneoplastic (CEA, sialyl-TN, p53, and bcl-2) features, and polyamine and PGE2 levels in patients with at least one previously resected colorectal adenoma.

• Determine the relationship between the modulation of SEB in flat mucosa and the development of interval incident colorectal adenomas in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to aspirin use (yes vs no) and participating center.

Patients receive oral placebo daily for the first 4 weeks. Patients who are compliant and take the placebo 5 to 7 days each week are randomized to one of two treatment arms.

• Arm I: Patients receive oral sulindac and oral eflornithine (DFMO) daily.

• Arm II: Patients receive oral placebo daily. Treatment continues for 3 years in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 240 patients (120 per treatment arm) will be accrued for this study within 18 months. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00005882
• Study type: Interventional
• Source: University of California, Irvine
• Status: Completed
• Phase: Phase 2
• Start date: June 2000
• Completion date: December 2011