A Phase I Study of Hepatic Arterial Infusion with Floxuridine, Dexamethasone, and Gemcitabine after Surgery for Liver Cholangiocarcinoma

Protocol
13-148
Full Title
Phase I Study of Hepatic Arterial Infusion with Floxuridine and Dexamethasone in Combination with Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
Phase
I
Purpose

Cholangiocarcinoma is a cancer of the bile ducts. Intrahepatic floxuridine (given into the liver) and intravenous gemcitabine (given by vein) are chemotherapy drugs that are used to treat this cancer, but they have never been assessed when given together directly into the liver.

In this study, researchers are finding the highest dose of the combination of these drugs that can be given safely (along with dexamethasone, an anti-inflammatory steroid drug) to patients with cholangiocarcinoma of the liver who are able to have their tumors surgically removed. Floxuridine and dexamethasone will be given directly into the liver through a pump implanted in the abdomen at the time of cancer surgery, and gemcitabine will be given intravenously.

Eligibility

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

  • Patients must have cholangiocarcinoma that is confined to the liver and is removed by surgery.
  • Patients may have had prior chemotherapy, but no floxuridine and no radiation therapy to the liver.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrea Cercek at 646-888-4189.

Disease(s)
Hepatobiliary: Liver Cancer
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