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Completed

NCT Number: NCT01572324

Study of Hepatic Arterial Infusion to Treat 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine

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.

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

Primary outcomes

  1. Response rates

    Time frame: 4 months

    Describe the overall response rate with a 95% confidence interval.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 6, 2012
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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