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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Washington University School of Medicine
St Louis, Missouri, United States
Dose-limiting toxicities (DLTs)
Document the frequency of grades 3-5 non-hematologic toxicities (dose-limiting toxicities) associated with the treatment regimen by patient and by type of toxicity for each cohort during the first 2 cycles of treatment
Time frame: Completion of 2 cycles of treatment by all patients (approximately 4 years)
Time to progression (TTP)
Describe median time to progression with a 95% confidence interval for each cohort.
Time frame: 12 months
Response rates
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started) Using RECIST 1.1
Time frame: 8 weeks
Overall survival
Time frame: 12 months
Number and grade of adverse events
Determine safety, tolerability and toxicities based on the number and grade of adverse events associated with this regimen.
Time frame: Beginning with pump placement and continuing for 30 days following the last day of study treatment (median length of treatment 3 months)
Imaging biomarkers of tumor response
Using magnetic resonance diffusion-weighted imaging (DW-MRI) and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) before and during the course of treatment with HAI therapy, validate imaging biomarkers of tumor response
Time frame: Pre-treatment and then every 8 weeks during treatment (median length of treatment 3 months)
Overall survival
Time frame: Up to 5 years
Time to progression (TTP)
Describe median time to progression with a 95% confidence interval for each cohort.
Time frame: 24 months
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