Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

NCT01572324 | Completed Phase 2 DMC

• 1 other identifier: PUCH12031308
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Keywords

Cholangiocarcinoma; gallbladder cancer; Infusions; Intra-Arterial

Outcome Measures

Primary Outcomes (1)

• Response rates

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

  4 months

Secondary Outcomes (3)

• Progress free survivial

  2 years

• Toxicity of HAI

  1 months

• Overall survival

  3 years

Study Arms (1)

Arterial infusion

EXPERIMENTAL

Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine

Interventions

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.

Also known as: 1-OHP, Dacotin, Eloxatin, L-OHP;, 5-Fluorouracil,5FU;, Levofolinic acid,Folinic acid.

Arterial infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xiaodong Wang, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

CN (1)