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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00501410 |
Purpose
Primary Objectives:
Secondary Objectives:
| 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 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
FOLFOX + Dasatinib + Cetuximab
|
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:
Childbearing potential is defined as a woman who is not post-menopausal for 12 months or longer or is not surgically sterile. Patients must agree to practice acceptable contraceptive methods.
Exclusion Criteria:
Recent (within 4 weeks of the first infusion of study drugs on this study), or planned participation in another experimental therapeutic drug study.
Patients who have had any systemic chemotherapy, radiotherapy, or major surgery within 28 days prior to the first infusion of study drugs.
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: | February 18, 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 Immunologic Factors Gastrointestinal Diseases Colonic Diseases Leucovorin Folate Rectal Diseases Protein Kinase Inhibitors Vitamin B9 Oxaliplatin Dasatinib Vitamins Micronutrients |
Digestive System Neoplasms Vitamin B Complex Cetuximab Trace Elements Intestinal Diseases Folinic Acid Immunosuppressive Agents Intestinal Neoplasms Folic Acid Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Protein Kinase Inhibitors Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Dasatinib |
Therapeutic Uses Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Cetuximab Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |