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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00501410 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of a combination of dasatinib, cetuximab and FOLFOX (5-fluorouracil [5-FU], leucovorin [LV], and Eloxatin [oxaliplatin]) that can be given to patients with metastatic colorectal cancer. The safety of these drugs in combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
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 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| FOLFOX + Dasatinib + Cetuximab: Experimental |
Drug: 5-FU
400 mg/m^2 by vein push on Day 1, followed by 2400 mg/m^2 by vein over 46 Hours On Days 1 & 2.
Drug: Cetuximab
Initial Dose = 400 mg/m^2 by vein, then 250 mg/m^2 Weekly On Days 1 & 8
Drug: Dasatinib
100 mg by mouth daily on days 1-14.
Drug: Leucovorin
400 mg/m^2 by vein on day 1.
Drug: Oxaliplatin
85 mg/m^2 by vein on day 1.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00501410 History of Changes |
| 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 Sprycel C225 Erbitux IMC-C225 Adrucil Efudex Folinic Acid |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Colonic Diseases Leucovorin Protein Kinase Inhibitors Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins |
Dasatinib Therapeutic Uses Micronutrients Vitamin B Complex Digestive System Neoplasms Hematinics Growth Substances Cetuximab Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Folic Acid Neoplasms |