drugset / Trial / NCT00507585

Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, Leucovorin, and Avastin

NCT00507585 ↗

Phase 1 Completed 63 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

PRIMARY: * To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every three weeks administered in combination with systemic intravenous Fluorouracil, Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the liver. SECONDARY: * To document in a descriptive fashion the antitumor efficacy of this combination regimen. * To evaluate the feasibility and accuracy of an alternate radiographic assessment tool and compare with available tumor markers and RECIST guidelines. * To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.

Timeline

Start
2006-06
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxaliplatin Small molecule 60 mg/m2 Other
Background Bevacizumab Monoclonal antibody 10 mg/m2 Intravenous
Background Leucovorin Small molecule 200 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous

Indications