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Sponsored by: |
ImClone Systems |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00835185 |
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer.
Condition | Intervention | Phase |
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Metastatic Colorectal Cancer |
Biological: IMC-11F8 Other: mFOLFOX-6 regimen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-Advanced or Metastatic Colorectal Cancer |
Estimated Enrollment: | 44 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
All patients will receive intravenous infusions of IMC-11F8 followed by administration of the mFOLFOX-6 regimen.
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Biological: IMC-11F8
Patients will receive IMC-11F8 800mg on Day 1 administered intravenously over 50 minutes. Followed by the mFOLFOX-6 regimen.
Other: mFOLFOX-6 regimen
Oxaliplatin 85mg/m2 intravenous infusion over 2 hours Day 1 Folinic Acid 400mg/m2 intravenous infusion over 2 hours Day 1 5-FU 400mg/m2 bolus injection immediately following folinic acid infusion 5-FU 2400mg/m2 intravenous infusion over 46 hours immediately following bolus injection (5-FU on Days 1 and 2
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The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-EGFR monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic colorectal cancer patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ImClone Systems ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP11-0602 |
Study First Received: | February 2, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00835185 History of Changes |
Health Authority: | Spain: Agencia Espanola Del Medicamento Y Productos Sanitarios; Spain: Comite de Investigacion Clinica Del Hospital Vall d' Hebron |
Antibodies, Monoclonal Colorectal Neoplasms |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Intestinal Neoplasms Antibodies, Monoclonal |
Folic Acid Antibodies Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |