Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572324
• Other study ID #: PUCH12031308
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2012
• Last updated: January 2, 2017
• Start date: March 2012
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates	Describe the overall response rate with a 95% confidence interval.	4 months	No
Secondary	Progress free survivial	Describe median PFS with a 95% confidence interval.	2 years	No
Secondary	Toxicity of HAI	Toxicity as measured by NCI Common Toxicity Criteria	1 months	Yes
Secondary	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	No