drugset / Trial / NCT00501410

FOLFOX Chemotherapy Regimen (5-FU, Leucovorin, Oxaliplatin) in Metastatic Colorectal Cancer

NCT00501410

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2007-04-23
Primary completion
2017-03-03
Completion
2017-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject dasatinib anhydrous Small molecule 100 mg Oral
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications