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Study 1 of 63 for search of: | Australia, Australian Capital Territory |
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Sponsors and Collaborators: |
ImClone Systems Bristol-Myers Squibb |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00063141 |
The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: cetuximab Drug: Irinotecan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma |
Enrollment: | 1302 |
Study Start Date: | April 2003 |
Study Completion Date: | October 2007 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental |
Drug: cetuximab
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
Drug: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
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Arm B: Active Comparator |
Drug: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | ImClone Systems | ImClone Systems |
Responsible Party: | ImClone Systems ( Eric Rowinsky, Chief Medical Officer ) |
Study ID Numbers: | CA225006 |
Study First Received: | June 20, 2003 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00063141 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Irinotecan Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Carcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |