Clinical trial NCT01572324: Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas
Official title: Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Keywords: Cholangiocarcinoma
gallbladder cancer
Infusions
Intra-Arterial
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Response rates
timeFrame: 4 months
Secondary outcomes:
measure: Progress free survivial
timeFrame: 2 years
measure: Toxicity of HAI
timeFrame: 1 months
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xiaodong Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: