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