Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

NCT ID: NCT01572324

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-04-30

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.

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arterial infusion

Group Type: EXPERIMENTAL

Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

1-OHP, Dacotin, Eloxatin, L-OHP; 5-Fluorouracil,5FU; Levofolinic acid,Folinic acid.

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Xiaodong Wang, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaodong Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PUCH12031308

Identifier Type: -

Identifier Source: org_study_id