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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01938729

Enrollment

Registered

2013-09-10

Start date

2013-09-05

Completion date

2020-09-10

Last updated

2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HEPATIC ARTERIAL INFUSION, FLOXURIDINE, DEXAMETHASONE, GEMCITABINE, Pump, 13-148

Brief 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.

Interventions

PROCEDURELiver resection and placement of hepatic artery infusion pump

DRUGFLOXURIDINE

DRUGDEXAMETHASONE

DRUGGEMCITABINE

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC). Confirmation of the diagnosis must be made at MSKCC or at the participating institution prior to initiating protocol therapy. * Technically resectable, single tumors of any size, tumors with satellite nodules within 2 cm of the primary tumor that are resectable. Limited and resectable multi-focal disease (less than 4 tumors technically resectable). * Patients with elevated liver function tests including jaundiced patients (due to tumor) can be selectively operated on without resolution of jaundice preoperatively according to the judgment of the operating surgeon * Patients must have a KPS \> 80% and be considered candidates for general anesthesia, hepatic resection and hepatic artery pump placement. * Laboratory values within 14 days before registration must be: * Serum albumin must be \>2.5 g/dl * Creatinine must be \< 1.8 mg/dL * WBC must be \>3500 cells/mm3 * Platelet count must be \>100,000/mm3 * International normalized ratio (INR) must be less than 1.5 in patients not on Coumadin therapy * Technically resectable, single tumors of any size, tumors with satellite nodules within 2 cm of the primary tumor that are resectable. Limited and resectable multi- focal disease (less than 4 tumors technically resectable). * Patients with elevated liver function tests including jaundiced patients (due to tumor) can be selectively operated on without resolution of jaundice preoperatively according to the judgment of the operating surgeon * Age \>18 years * Patients must be able to understand and sign informed consent * Prior chemotherapy is allowed

Exclusion criteria

* Prior treatment with HAI chemotherapy * Extrahepatic metastases including nodal disease * Prior external beam radiation therapy to the liver * Diagnosis of sclerosing cholangitis * Diagnosis of Gilbert's disease * Clinical ascites * Hepatic encephalopathy * Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage * Patients with occlusion of the main portal vein or of the right and left portal branches * Patients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers) * Female patients who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame	Description
Safety and Toxicity	1 year	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.

Secondary

Measure	Time frame	Description
Recurrence Free Survival	1 year	we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026