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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00501410 |
Purpose
The goal of the Phase I part 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.
The goal of the Phase II part of this clinical research study is to learn if dasatinib given in combination with FOLFOX with or without cetuximab can help to control metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: 5-FU Drug: Cetuximab Drug: Dasatinib Drug: Leucovorin Drug: Oxaliplatin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dual Inhibition of EGFR and c-Src by Cetuximab and Dasatinib Combined With FOLFOX Chemotherapy in Metastatic Colorectal Cancer (CA180048) |
| Estimated Enrollment: | 83 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FOLFOX + Dasatinib + Cetuximab |
Drug: 5-FU
2400 mg/m^2 by vein over 46 Hours On Days 1 & 2.
Other Name: 5-Fluorouracil
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.
Other Name: BMS-354825
Drug: Leucovorin
400 mg/m^2 by vein on day 1.
Other Name: Folinic Acid
Drug: Oxaliplatin
85 mg/m^2 by vein on day 1.
Other Name: Eloxatin
|
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 | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Scott Kopetz, MD | |
| Principal Investigator: | Scott Kopetz, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00501410 History of Changes |
| Other Study ID Numbers: | 2005-0842 |
| Study First Received: | July 12, 2007 |
| Last Updated: | December 1, 2011 |
| 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 |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Cetuximab Leucovorin |
Folic Acid Levoleucovorin Dasatinib Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |