Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Peking University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Xiaodong Wang, MD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Cholangiocarcinoma; gallbladder cancer; Infusions; Intra-Arterial
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Capecitabine; Oxaliplatin; Leucovorin
• Other Study ID Numbers: PUCH12031308