Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

Study Overview
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Brief Summary
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This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.

Official Title
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Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer without evident liver metastasis. Patient must have locally advanced disease that is unresectable after review by the Hepatobiliary Surgery service Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Hemoglobin >= 90g/L Total bilirubin =< 2 X institutional upper limit of normal Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normality Creatinine =< 1.5 X institutional upper limit of normal Albumin >= 30g/L Patient must be able to understand and willing to sign a written informed consent document Exclusion Criteria: Patients who have had prior chemotherapy and other antitumor therapy treatment Patient who is receiving any other investigational agents Patient who have evident distant (M) disease; Patient who have a diagnosis of hepatic encephalopathy Patients who have a diagnosis of sclerosing cholangitis. Patients who have a diagnosis of Gilbert's disease. Patients who have clinical ascites Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years Patient who is pregnant or lactating Patient Allergic to Iodine contrast medium Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin therapy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arterial infusion<br> | Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine<br>* HAI of Oxaliplatin and Fluorouracil: Oxaliplatin 130mg/m2 in split daily doses for 3 days, Fluorouracil 3000 mg/m2 in split daily doses for 3 days. Intraarterial Oxaliplatin plus intravenous Leucovorin 200 mg/m2 simultaneously over 2 hours followed by intraarterial Fluorouracil over 22 hours on Days 1-3 of each cycle, repeat every 21 days. After 4-6 cycles of HAI, maintenance treatment continue, Maintenance of Oral capecitabine 1,000 mg/m2 twice a day from days 1-14, Cycles were repeated every 21 days.<br>* Other names: Levofolinic acid,Folinic acid.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates | Describe the overall response rate with a 95% confidence interval. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survivial | Describe median PFS with a 95% confidence interval. | 2 years | 
| Toxicity of HAI | Toxicity as measured by NCI Common Toxicity Criteria | 1 months | 
| Overall survival | Describe median overall survival with a 95% confidence interval and estimate the overall survival rate at 12 and 24 months with 24 months with a 95% confidence interval. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, gallbladder cancer, Infusions, Intra-Arterial