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Safety Study of Oxaliplatin and 5-fluorouracil Followed by FUDR for Unresectable Colorectal Liver Metastases

Colorectal Liver Metastases Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicity of 5-FU in combination with Oxaliplatin delivered via isolated hepatic perfusion.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00557557
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase Phase 1
Start date July 2007
Completion date August 2014
View Details
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