A Phase II Study of Hepatic Arterial Infusion with Floxuridine and Dexamethasone plus Systemic Gemcitabine and Oxaliplatin in Patients with Inoperable Intrahepatic Cholangiocarcinoma

Protocol
13-066
Full Title
A Phase II Study of Hepatic Arterial Infusion (HAI) with Floxuridine (FUDR) and Dexamethasone (Dex) Combined with Systemic Gemcitabine and Oxaliplatin in Patients with Unresectable Intrahepatic Cholangiocarcinoma (ICC)
Phase
II
Purpose

The purpose of this study is to evaluate the combination of two approaches to delivering chemotherapy for liver tumors. One approach, hepatic arterial infusion, delivers chemotherapy directly to the liver through a small metal pump surgically implanted in the abdomen. The second approach is intravenous chemotherapy, which is given by vein.

In this study, researchers are evaluating hepatic arterial infusion with the drugs floxuridine and dexamethasone in combination with systemic treatment using gemcitabine and oxaliplatin in patients with a type of liver tumor called cholangiocarcinoma that cannot be surgically removed. They are also assessing a form of magnetic resonance imaging to measure the response of the tumor to treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable cholangiocarcinoma of the liver.
  • Patients may have had prior therapy, but not floxuridine nor radiation therapy to the liver.
  • Patients whose cancer continued to grow despite previous treatment with gemcitabine or oxaliplatin may not participate.
  • This study is open to patients age 21 and older.

For more information and to inquire about eligibility for this study, please contact Dr. William Jarnagin at 212-639-7601 or Dr. Nancy Kemeny at 646-888-4180.

Disease(s)
Hepatobiliary: Liver Cancer
Locations
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