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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
To determine the maximum tolerated dose and dose limiting toxicity of oxaliplatin delivered via isolated hepatic perfusion (IHP).
Time frame: 12 months
To determine if isolated hepatic perfusion with oxaliplatin can increase the response rate, duration of response and survival of patients being treated with standard HAI with FUDR when compared to historical controls.
Time frame: 2-3 years
To determine the tissue absorption of oxaliplatin in normal liver versus tumor during IHP.
Time frame: 12 months
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