NCT01042691

Isolated Liver Perfusion With Oxaliplatin

A Phase I Trial of Isolated Hepatic Perfusion With Oxaliplatin Followed by Hepatic Arterial Infusion of FUDR and Leucovorin for Patients With Unresectable Colorectal Liver Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: David Bartlett · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this research study is to determine a safe dose for the drug oxaliplatin when delivered by isolated hepatic perfusion. The second goal of this research study is to determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard hepatic arterial infusional (HAI) therapy with floxuridine (FUDR)/leucovorin.

Conditions

• Unresectable Colorectal Liver Metastases

Interventions

Type	Name	Description
DRUG	Oxaliplatin	The starting dose of oxaliplatin administered via isolated hepatic perfusion will be the safe tolerated dose of intra-arterial infusion and pharmacokinetics from intravenous studies. The dose will be 5 mg/m2 and will be escalated.

Timeline

• Start date: 2003-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-01-05
• Last updated: 2017-12-20

Locations

3 sites across 1 country: United States