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

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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 call 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).

Eligibility

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

  • Patients must have inoperable intrahepatic cholangiocarcinoma that has not yet been treated.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for 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.

Protocol

20-348

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators