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

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