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Sponsors and Collaborators: |
Bristol-Myers Squibb Merck |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00362102 |
To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.
Condition | Intervention | Phase |
---|---|---|
Colorectal Carcinoma |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open Label, Non-Randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-Detectable Metastatic Colorectal Carcinoma |
Estimated Enrollment: | 38 |
Study Start Date: | October 2005 |
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CA225-259 |
Study First Received: | August 8, 2006 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00362102 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Cetuximab Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |