Status:
TERMINATED
Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma
Lead Sponsor:
Washington University School of Medicine
Conditions:
Cholangiocarcinoma
Liver Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01525069
Start Date
April 3 2012
End Date
August 2 2022
Last Update
August 10 2022
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110