NCT01938729

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intrahepatic Cholangiocarcinoma
• Peripheral Cholangiocarcinoma
• Cholangiolar Carcinoma
• Cholangiocellular Carcinoma) (ICC)

Interventions

Type	Name	Description
PROCEDURE	Liver resection and placement of hepatic artery infusion pump
DRUG	FLOXURIDINE
DRUG	DEXAMETHASONE
DRUG	GEMCITABINE

Timeline

• Start date: 2013-09-05
• Primary completion: 2020-09-10
• Completion: 2020-09-10
• First posted: 2013-09-10
• Last updated: 2020-09-11

Locations

5 sites across 1 country: United States