Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas
This study is currently recruiting participants.
Verified November 2012 by Peking University
Sponsor:
Peking University
Information provided by (Responsible Party):
Xiaodong Wang, MD, Peking University
ClinicalTrials.gov Identifier:
NCT01572324
First received: April 4, 2012
Last updated: November 28, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Biliary Tract Cancer |
Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Capecitabine
U.S. FDA Resources
Further study details as provided by Peking University:
Primary Outcome Measures:
- Progress free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Describe median PFS with a 95% confidence interval.
Secondary Outcome Measures:
- Response rates [ Time Frame: 1 years ] [ Designated as safety issue: No ]Describe the overall response rate with a 95% confidence interval.
- Toxicity of HAI [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]Toxicity as measured by NCI Common Toxicity Criteria
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 37 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer with or without 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 N2 or distant (M) disease; (patients with limited N1 disease are eligible)
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572324
Contacts
| Contact: Xiaodong Wang, MD | 008610-88196476 | wangxde@gmail.com |
Locations
| China, Beijing | |
| Peking University Cancer Hospital | Recruiting |
| Beijing, Beijing, China, 100142 | |
| Contact: Xiaodong Wang, MD 008610-88196476 wangxde@gmail.com | |
| Sub-Investigator: Guang Cao, MD | |
| Sub-Investigator: Hui Chen, MD | |
| Sub-Investigator: Jianhai Guo, MD | |
| Sub-Investigator: Haifeng Xu, MD | |
| Sub-Investigator: Peng Liu, MD | |
Sponsors and Collaborators
Peking University
Investigators
| Principal Investigator: | Xiaodong Wang, MD | Peking University Cancer hospital & Institute |
More Information
No publications provided
| Responsible Party: | Xiaodong Wang, MD, MD, Peking University |
| ClinicalTrials.gov Identifier: | NCT01572324 History of Changes |
| Other Study ID Numbers: | PUCH12031308 |
| Study First Received: | April 4, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Peking University:
|
Cholangiocarcinoma gallbladder cancer Infusions Intra-Arterial |
Additional relevant MeSH terms:
|
Carcinoma Biliary Tract Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Biliary Tract Diseases Digestive System Diseases Fluorouracil Capecitabine Oxaliplatin Leucovorin Levoleucovorin Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013