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Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer

NCT00983580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-09-04

Study results available
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Summary

This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.

Conditions

  • Adenomatous Polyp

Interventions

DRUG

Aspirin

Given PO

DRUG

Eflornithine

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative study

OTHER

Placebo

Given PO

OTHER

Telephone-Based Intervention

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Frank A Sinicrope · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-20
Primary Completion
2016-10-07
Completion
2019-08-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983580 on ClinicalTrials.gov