An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

October 26, 2015 updated by: Eli Lilly and Company
The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • Spain
      • Barcelona, Spain
        • Local Institution
  • United States
    • California
      • Duarte, California, United States
        • Local Institution
    • Florida
      • Tampa, Florida, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Local Institution
    • New York
      • Bronx, New York, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
      • Cleveland, Ohio, United States
        • Local Institution
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • San Antonio, Texas, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Measurable disease Tumor available for biopsies. Life expectancy of at least 3 months.

Exclusion Criteria:

  • Known or documented brain metastases prior to Cetuximab therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Cetuximab
IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.
Other Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary Outcome Measures

Outcome Measure
Radiographic Response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA225-045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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