A Phase I Trial of Isolated Hepatic Perfusion With Oxaliplatin and 5-fluorouracil (5-FU) Followed by Hepatic Arterial Infusion of FUDR for Patients With Unresectable Colorectal Liver Metastases
Subjects who are planning to undergo surgery for placement of HAI therapy pump will be
considered for enrollment. Standard HAI therapy requires a laparotomy and placement of an
intrahepatic arterial catheter that is connected to one of several commercially available
subcutaneous electronic pumps. The pump is then used to deliver FUDR directly to the liver,
usually beginning four weeks after surgery and lasts on average for a period of six to
twelve months after the study. Current HAI therapy regimens often alternate FUDR with
systemic chemotherapy. This study will examine the addition of a one hour isolated hepatic
perfusion with 5-FU and Oxaliplatin prior to this standard treatment. Subjects will be
given the consent form to review and after sufficient time to review the information,
interested subjects will have the opportunity to ask questions of the investigators.
Subjects interested in enrolling in the trial will then sign informed consent and clinical
data will be collected from their chart to ensure that they meet eligibility requirements.
The study will consist of a one hour isolated liver perfusion that will be performed at the
time of the laparotomy to place the HAI therapy pump. Following surgery subjects will be
monitored in the ICU for 24-48 hours and potentially in the hospital for an additional 5-7
days. Subjects will be free to start standard HAI therapy regimens four to six weeks
following surgery. The duration of treatment, dose of HAI therapy and the decision to
combine HAI with systemic chemotherapy will be at the discretion of the treating physician.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary endpoint is to determine the maximum tolerated dose and dose limiting toxicity of 5-FU delivered with 40mg/m² of Oxaliplatin via IHP.
24 to 48 hours
Herbert J. Zeh, MD
University of Pittsburgh
United States: Food and Drug Administration
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