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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00207155
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to predict response to Erbitux as a single agent in patients with metastatic colon cancer

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Cetuximab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer
Study Start Date : December 2003
Primary Completion Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

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 Name: Erbitux



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

Secondary Outcome Measures :
  1. Radiographic Response


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207155


Locations
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
Spain
Local Institution
Barcelona, Spain
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00207155     History of Changes
Other Study ID Numbers: CA225-045
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents