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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00501410 |
Primary Objectives
Secondary Objectives
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: 5-FU Drug: Cetuximab Drug: Dasatinib Drug: Leucovorin Drug: Oxaliplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dual Inhibition of EGFR and c-Src by Cetuximab and Dasatinib Combined With FOLFOX Chemotherapy in Metastatic Colorectal Cancer (CA180048) |
Estimated Enrollment: | 42 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
FOLFOX + Dasatinib + Cetuximab
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Drug: 5-FU
400 mg/m^2 IV Push On Day 1, Followed by 2400 mg/m^2 IV Over 46 Hours On Days 1 & 2.
Drug: Cetuximab
Initial Dose = 400 mg/m^2 IV, then 250 mg/m^2 Weekly On Days 1 & 8
Drug: Dasatinib
100 mg PO Daily On Days 1-14.
Drug: Leucovorin
400 mg/m^2 IV On Day 1.
Drug: Oxaliplatin
85 mg/m^2 IV On Day 1.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion:
Contact: Scott Kopetz, MD | 713-792-2828 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Scott Kopetz, MD |
Principal Investigator: | Scott Kopetz, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Scott Kopetz, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0842 |
Study First Received: | July 12, 2007 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00501410 |
Health Authority: | United States: Institutional Review Board |
Colorectal Cancer Dual Inhibition of EGFR FOLFOX Chemotherapy 5-FU Cetuximab Dasatinib |
Leucovorin Oxaliplatin 5-Fluorouracil BMS-354825 Eloxatin |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Cetuximab Leucovorin Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Dasatinib Fluorouracil Gastrointestinal Neoplasms 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 |
Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |