Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Peking University
Sponsor:
Information provided by (Responsible Party):
Xiaodong Wang, MD, Peking University
ClinicalTrials.gov Identifier:
NCT01572324
First received: April 4, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Biliary Tract Cancer
Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Progress free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Describe median PFS with a 95% confidence interval.


Secondary Outcome Measures:
  • Response rates [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    Describe the overall response rate with a 95% confidence interval.

  • Toxicity of HAI [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
    Toxicity as measured by NCI Common Toxicity Criteria

  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 37
Study Start Date: March 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arterial infusion Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
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.
Other Names:
  • 1-OHP, Dacotin, Eloxatin, L-OHP;
  • 5-Fluorouracil,5FU;
  • Levofolinic acid,Folinic acid.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer with or without 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 N2 or distant (M) disease; (patients with limited N1 disease are eligible)
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572324

Contacts
Contact: Xiaodong Wang, MD 008610-88196476 wangxde@gmail.com

Locations
China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Xiaodong Wang, MD    008610-88196476    wangxde@gmail.com   
Sub-Investigator: Guang Cao, MD         
Sub-Investigator: Hui Chen, MD         
Sub-Investigator: Jianhai Guo, MD         
Sub-Investigator: Haifeng Xu, MD         
Sub-Investigator: Peng Liu, MD         
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Xiaodong Wang, MD Peking University Cancer hospital & Institute
  More Information

No publications provided

Responsible Party: Xiaodong Wang, MD, MD, Peking University
ClinicalTrials.gov Identifier: NCT01572324     History of Changes
Other Study ID Numbers: PUCH12031308
Study First Received: April 4, 2012
Last Updated: November 28, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Cholangiocarcinoma
gallbladder cancer
Infusions
Intra-Arterial

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014