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

This study has been completed.

First Received: September 12, 2005 Last Updated: July 10, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00207155

Purpose

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastic Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Prediction of response to Erbitux in subjects with metastatic colorectal cancer

Secondary Outcome Measures:

Radiographic Response

Estimated Enrollment:

110

Arms	Assigned Interventions
A: Experimental	Drug: Cetuximab IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Cleveland, Ohio, United States
Local Institution
Cincinnati, Ohio, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Hershey, 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

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CA225-045
Study First Received:	September 12, 2005
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00207155 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009