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

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: October 26, 2015
Last verified: October 2015
The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Cetuximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary Outcome Measures:
  • Radiographic Response

Estimated Enrollment: 110
Study Start Date: December 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Cetuximab
IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.
Other Name: Erbitux


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00207155

United States, California
Local Institution
Duarte, California, United States
United States, Florida
Local Institution
Tampa, Florida, United States
United States, Maryland
Local Institution
Baltimore, Maryland, United States
United States, Missouri
Local Institution
St. Louis, Missouri, United States
United States, New Jersey
Local Institution
New Brunswick, New Jersey, United States
United States, New York
Local Institution
Bronx, New York, United States
United States, Ohio
Local Institution
Cincinnati, Ohio, United States
Local Institution
Cleveland, Ohio, United States
United States, Pennsylvania
Local Institution
Hershey, Pennsylvania, United States
Local Institution
Philadelphia, Pennsylvania, United States
United States, Tennessee
Local Institution
Nashville, Tennessee, United States
United States, Texas
Local Institution
San Antonio, Texas, United States
Canada, Quebec
Local Institution
Montreal, Quebec, Canada
Local Institution
Barcelona, Spain
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company Identifier: NCT00207155     History of Changes
Other Study ID Numbers: CA225-045
Study First Received: September 12, 2005
Last Updated: October 26, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on November 30, 2015