Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:April 3, 2012
End Date:January 19, 2024

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

This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial
infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic
drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by
surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver
tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or
gemcitabine may significantly improve clinical outcomes of patients with locally advanced
cholangiocarcinoma.


Inclusion Criteria:

- Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal
extrahepatic disease. Diagnosis must be histologically or cytologically confirmed for
continued treatment on study after pump placement.

- 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 <= institutional upper limit normal

- 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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-7792
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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