PHASE I EVALUATION OF A MODIFIED HEPATIC ARTERY INFUSION CATHETER

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The purpose of this protocol is to examine the efficacy and toxicity of intraarterial fluorogeoxyuridine (FUDR) and oral leucovorin using a modified hepatic artery catheter in combination with system administration of 5-fluorouracil (5FU) and alpha interferon for patients with colon cancer metastatic to the liver. Intraarterial infusion of FUDR using standard infusion catheters produces a high response rate but is associated with significant hepatic toxicity. The major complications of intraarterial infusion are accidental extra-hepatic delivery of chemotherapy, chemical hepatitis, chemical cholecystitis and a potentially lethal complication of biliary sclerosis. A modified hepatic artery catheter has been developed that produces turbulence as a result of the inflation of a balloon at the catheter tip. The balloon hepatic artery catheter produces turbulence and allows mixing of the infusate with blood and may prevent complications associated with the currently employed catheters. Extrahepatic progression of metastatic colon cancer is the other problem associated with hepatic artery infusion therapy. A very effective chemoimmunotherapy regimen consisting of 5FU and alpha interferon will be combined with intra-arterial FUDR in an attempt to control metastatic disease outside of the liver.