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Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

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ClinicalTrials.gov Identifier: NCT01572324
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Primary Completion Date : October 2015
Study Completion Date : April 2016


Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Response rates [ Time Frame: 4 months ]
    Describe the overall response rate with a 95% confidence interval.


Secondary Outcome Measures :
  1. Progress free survivial [ Time Frame: 2 years ]
    Describe median PFS with a 95% confidence interval.

  2. Toxicity of HAI [ Time Frame: 1 months ]
    Toxicity as measured by NCI Common Toxicity Criteria

  3. Overall survival [ Time Frame: 3 years ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572324


Locations
China, Beijing
Peking University Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Xiaodong Wang, MD Peking University Cancer hospital & Institute
More Information

Responsible Party: Xiaodong Wang, MD, MD, Peking University
ClinicalTrials.gov Identifier: NCT01572324     History of Changes
Other Study ID Numbers: PUCH12031308
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Xiaodong Wang, MD, Peking University:
Cholangiocarcinoma
gallbladder cancer
Infusions
Intra-Arterial

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