FOLFOX Chemotherapy Regimen (5-FU, Leucovorin, Oxaliplatin) in Metastatic Colorectal Cancer
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.
|Study Design:||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)|
- Maximum Tolerated Dose (MTD) of Dasatinib, Cetuximab and FOLFOX [ Time Frame: 2 Week Cycles ] [ Designated as safety issue: Yes ]
- Dose Limiting Toxicity (DLT) of Dasatinib, Cetuximab and FOLFOX [ Time Frame: 2 Week Cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: FOLFOX + Dasatinib + Cetuximab
5-FU 2400 mg/m^2 by vein over 46 Hours On Days 1 & 2. Cetuximab initial dose = 400 mg/m^2 by vein, then 250 mg/m^2 Weekly On Days 1 & 8. Dasatinib 100 mg by mouth daily on days 1-14. Leucovorin 400 mg/m^2 by vein on day 1. Oxaliplatin 85 mg/m^2 by vein on day 1.
2400 mg/m^2 by vein over 46 Hours On Days 1 & 2.
Other Name: 5-FluorouracilDrug: Cetuximab
Initial Dose = 400 mg/m^2 by vein, then 250 mg/m^2 Weekly On Days 1 & 8Drug: Dasatinib
Starting dose level: 100 mg by mouth daily on days 1-14.
Other Name: BMS-354825Drug: Leucovorin
400 mg/m^2 by vein on day 1.
Other Name: Folinic AcidDrug: Oxaliplatin
85 mg/m^2 by vein on day 1.
Other Name: Eloxatin
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Scott Kopetz, MD||M.D. Anderson Cancer Center|