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Sponsored by: |
Merck KGaA |
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Information provided by: | EMD Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00154102 |
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil/Folinic acid plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the EGF receptor.
Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.
After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.
The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.
Condition | Intervention | Phase |
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EGFR-Expressing Metastatic Colorectal Cancer |
Drug: Cetuximab, 5-Fluorouracil, Folinic acid, Irinotecan Drug: 5-Fluorouracil, Folinic acid, Irinotecan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-Line Treatment for Epidermal Growth Factor Receptor-Expressing Metastatic Colorectal Cancer |
Enrollment: | 1221 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Cetuximab, 5-Fluorouracil, Folinic acid, Irinotecan
Cetuximab intravenous infusion of 400mg/m2 for the first infusion then weekly intravenous infusion of 250mg/m2. Bi-weekly Irinotecan infusion of 180mg/m2, Folinic Acid infusion of 400mg/m2 (racemic) or 200mg/m2 (L-form), 5-Fluorouracil bolus of 400mg/m2 followed by a 46-hour continuous infusion of 2400mg/m2 Number of Cycles: until progression or unacceptable toxicity develops
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2: Active Comparator |
Drug: 5-Fluorouracil, Folinic acid, Irinotecan
Bi-weekly Irinotecan infusion of 180mg/m2, Folinic Acid infusion of 400mg/m2 (racemic) or 200mg/m2 (L-form), 5-Fluorouracil bolus of 400mg/m2 followed by a 46-hour continuous infusion of 2400mg/m2 Number of Cycles: until progression or unacceptable toxicity develops
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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:
Principal Investigator: | Eric van Cutsem, Professor | University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium |
Responsible Party: | Merck KGaA ( Patrick Lebrun ) |
Study ID Numbers: | EMR 62202-013 |
Study First Received: | September 8, 2005 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00154102 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Metastatic colorectal cancer EGFR Irinotecan cetuximab first-line treatment |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Cetuximab Leucovorin Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Methamphetamine Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Amphetamine Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Antineoplastic Agents, Phytogenic |