CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Oxaliplatindrug
Likely dose
Oxaliplatin 5 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01042691
NCT01042691Phase 1Completed
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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

David Bartlett·interventional·Posted Jan 5, 2010·Updated Dec 20, 2017

In Brief

A Phase 1 clinical trial evaluating Oxaliplatin for Unresectable Colorectal Liver Metastases. Completed, enrolled 10 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnresectable Colorectal Liver Metastases
CountriesUnited States
CollaboratorsThe Pittsburgh Foundation, Sanofi

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 5, 2010
Enrollment StartMay 1, 2003
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 16.5 years ago

Interventions

Oxaliplatindrug

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.