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This is an open-label single arm study. multi-institution phase I dose escalating trial of adjuvant HAIP FUDR and Gemcitabine chemotherapy after curative resection of ICC. Hepatectomy with or without bile duct reconstruction and pump placement are performed. The patients will start therapy 4 weeks postoperatively. They will receive HAI FUDR/Dex and systemic gemcitabine in the following dose escalation levels of gemcitabine. The dose of HAI FUDR will be fixed. A classic 3+3 cohort dose escalation scheme will be used to identify the MTD of the combination.

Level 1: Systemic gemcitabine 650mg/m\^2 Day 1 and 15 and HAI FUDR/Dex 0.12mg/kg/day Day 1-14 Level 2.Systemic gemcitabine 800mg/m\^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14 Level 3. Systemic gemcitabine 1000mg/m\^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14

Liver resection and placement of hepatic artery infusion pump

FLOXURIDINE

DEXAMETHASONE

GEMCITABINE

Andrea Cercek, MD

This is a Phase I study, which means we want to find out what effects, good and/or bad, this combination of drugs may have on the patient and the liver cancer at different dose levels. All patients will have an operation to remove tumors in the liver and may have a pump placed in their abdomen.

On this study, both drugs given have been used in other patients for treatment of cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been combined in a few patients.

That means that in this trial we also want to find out if this combination is safe.

The study will also evaluate if this treatment works in delaying or stopping the cancer from coming back after surgery.

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

All toxicities will be rated as per the NCI Common Toxicity Criteria (CTC AE version 4.0) except neurosensory and hepatic enzyme toxicities related to intrahepatic pump therapy.

we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.

Ohio State University

University of Texas Southwestern Medical Center

Washington University School of Medicine

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma	NCT01938729	Intrahepatic Ch... Peripheral Chol... Cholangiolar Ca... Cholangiocellul...	Liver resection... FLOXURIDINE DEXAMETHASONE GEMCITABINE	18 Years -	Memorial Sloan Kettering Cancer Center
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma	NCT01938729	Intrahepatic Ch... Peripheral Chol... Cholangiolar Ca... Cholangiocellul...	Liver resection... FLOXURIDINE DEXAMETHASONE GEMCITABINE	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for cholangiocellular carcinoma) (icc)