Back to resultsStudy of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas
Primary Purpose
Biliary Tract Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Cholangiocarcinoma, gallbladder cancer, Infusions, Intra-Arterial
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)
Sites / Locations
- Peking University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arterial infusion
Arm Description
Outcomes
Primary Outcome Measures
Response rates
Describe the overall response rate with a 95% confidence interval.
Secondary Outcome Measures
Progress free survivial
Describe median PFS with a 95% confidence interval.
Toxicity of HAI
Toxicity as measured by NCI Common Toxicity Criteria
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01572324
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
Cholangiocarcinoma, gallbladder cancer, Infusions, Intra-Arterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arterial infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
Other Intervention Name(s)
1-OHP, Dacotin, Eloxatin, L-OHP;, 5-Fluorouracil,5FU;, Levofolinic acid,Folinic acid.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rates
Description
Describe the overall response rate with a 95% confidence interval.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Progress free survivial
Description
Describe median PFS with a 95% confidence interval.
Time Frame
2 years
Title
Toxicity of HAI
Description
Toxicity as measured by NCI Common Toxicity Criteria
Time Frame
1 months
Title
Overall survival
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Wang, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas
We'll reach out to this number within 24 hrs