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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00207155
First received: September 12, 2005
Last updated: April 11, 2011
Last verified: April 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00207155     History of Changes
Other Study ID Numbers: CA225-045
Study First Received: September 12, 2005
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014