Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma

Inclusion Criteria:

- Patient must have histologically or cytologically confirmed intrahepatic or hilar
cholangiocarcinoma with minimal extrahepatic disease

- Patient must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as >=
20 mm with conventional techniques or as >= 10 mm with spiral computed tomography
(CT) scan/MRI

- Patient must have disease that is unresectable or borderline resectable with < 70%
liver involvement by cancer

- Patient must be >= 18 years old.

- Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2
(Karnofsky >= 60%)

- Patient must have normal organ and marrow function as defined below:

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 75,000/mcL

- Total bilirubin =< 2 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])
=< 5 X institutional upper limit of normal

- Creatinine within normal institutional limits

- Patient must be able to understand and willing to sign a written informed consent
document

Exclusion Criteria:

- Patients must not have had prior treatment with FUDR

- Patient must not be receiving any other investigational agents

- Patient must not have a diagnosis of Gilbert's disease

- Patient must not have a diagnosis of hepatic encephalopathy

- Patient must not have had prior external beam radiation to the liver

- Patient must not have a diagnosis of sclerosing cholangitis

- Patient must not have any uncontrolled intercurrent illness including, but not
limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements

- Patient must not be pregnant or breastfeeding