drugset / Trial / NCT00941499

Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab

NCT00941499

Phase 1 Completed 140 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.

Timeline

Start
2009-07
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Cetuximab Monoclonal antibody 125 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject fluorouracil Small molecule 300 mg/m2 Other
Subject fluorouracil Small molecule 400 mg/m2 Other
Subject fluorouracil Small molecule 600 mg/m2 Other
Subject fluorouracil Small molecule 900 mg/m2 Other
Subject fluorouracil Small molecule 1000 mg/m2 Other
Subject fluorouracil Small molecule 1750 mg/m2 Other
Background Oxaliplatin Small molecule 140 mg/m2 Other