A Phase II Study of Gemcitabine and Oxaliplatin Chemotherapy with or without a Floxuridine and Dexamethasone Pump in People with Inoperable Cholangiocarcinoma

Full Title

A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

Purpose

Gemcitabine and oxaliplatin (GemOx) is a standard chemotherapy combination used to treat a cancer of the bile ducts called cholangiocarcinoma. In this study, researchers want to see if adding another treatment that is delivered by a pump device (hepatic arterial infusion or HAI) to GemOx therapy is more effective than GemOx alone for patients with previously untreated inoperable cholangiocarcinoma. The HAI pump, which is implanted in the abdomen during a surgical procedure, continuously delivers the drugs floxuridine and dexamethasone directly to the liver.

Patients in this study will be randomly assigned to receive GemOx alone or with HAI pump therapy (floxuridine and dexamethasone). GemOx is given intravenously (by vein).