A Phase II Multicenter Study of Erbitux (Cetuximab) in Patients With Refractory, EGFR-Negative Metastatic Colorectal Carcinoma
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With an Overall Resonse
Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.
Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.
No
E-mail: ClinicalTrials@ ImClone.com
Study Chair
ImClone LLC
United States: Food and Drug Administration
CP02-0451
NCT00083720
October 2004
April 2008
Name | Location |
---|---|
ImClone Investigational Site | Indianapolis, Indiana 46202 |
ImClone Investigational Site | New York, New York 10021 |
ImClone Investigational Site | St. Charles, Missouri 63301 |
ImClone Investigational Site | Bakersfield, California 93309 |
ImClone Investigational Site | Jacksonville, Florida 32207 |
ImClone Investigational Site | Decatur, Illinois 62526 |
ImClone Investigational Site | Louisville, Kentucky 40202 |
ImClone Investigational Site | New Orleans, Louisiana 70121 |
ImClone Investigational Site | Ypsilanti, Michigan 48198 |
ImClone Investigational Site | Dallas, Texas 75230 |
ImClone Investigational Site | Winston-Salem, North Carolina 27103 |
ImClone Investigational Site | Philadelphia, Pennsylvania 19107 |
ImClone Investigational Site | Boston, Massachusetts 02135 |