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NCT00207155 Clinical Trial

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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00207155
Other study ID # CA225-045
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated October 26, 2015
Start date December 2003
Est. completion date February 2006

Study information
Verified date October 2015
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cetuximab
IV solution, IV, 400 mg/m2 initial dose + 250-400 mg/m2 weekly, Weekly, Until disease progression.

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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of response to Erbitux in subjects with metastatic colorectal cancer
Secondary Radiographic Response
See also
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Active, not recruiting NCT02575378 - Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer Phase 4
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Completed NCT02414009 - Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients Phase 2
Active, not recruiting NCT01949194 - Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers Phase 2
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