Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-03

Study Completion Date

2022-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

NCT01938729

Intrahepatic Cholangiocarcinoma Peripheral Cholangiocarcinoma Cholangiolar Carcinoma +1 more

COMPLETED PHASE1

A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

NCT00587067

Hepatic Cancer

COMPLETED PHASE2

Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE

NCT02557503

Advanced Adult Primary Liver Cancer

UNKNOWN PHASE4

Hepatic Artery Infusion With FOLFOX in Liver Metastasis From Breast Cancer

NCT01937507

Metastatic Breast Cancer

TERMINATED PHASE2

Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

NCT03722498

Hepatocellular Carcinoma

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholangiocarcinoma Liver Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A (HAI FUDR alone)

* 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
* This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
* The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.

Group Type EXPERIMENTAL

Floxuridine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Arm B (HAI FUDR + gemcitabine)

* Consists of Cohort B1, B2, and B3. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR and gemcitabine.
* Gemcitabine IV will be given on Days 1, 8, and 15 of each 28 day cycle in Cohort B1
* Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle in Cohort B2 \& B3
* 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
* This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
* The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.

Group Type EXPERIMENTAL

Floxuridine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Arm C (HAI FUDR + gemcitabine + oxaliplatin)

* Consists of Cohort C1, C2, C3, and C4. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR, gemcitabine, and oxaliplatin.
* Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle.
* Oxaliplatin IV will be given on Days 1 and 15 of each 28 days cycle.
* 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
* This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
* The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.

Group Type EXPERIMENTAL

Floxuridine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Floxuridine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

5-FUDR, FdUrD, floxuridin, fluorodeoxyuridine, fluoruridine deoxyribose, FUdR Aeroseb-Dex, Decaderm, Decadron, Decaspray, DM, DXM dFdC, dFdCyd, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar, LY-188011 1-OHP, Dacotin, Dacplat, diaminocyclohexane oxalatoplatinum, Eloxatin, L-OHP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease. Diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement.
* Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan/MRI
* Patient must have disease that is unresectable or borderline resectable with \< 70% liver involvement by cancer
* Patient must be \>= 18 years old.
* Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
* Patient must have normal organ and marrow function as defined below:

* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 75,000/mcL
* Total bilirubin =\< 2 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 5 X institutional upper limit of normal
* Creatinine \<= institutional upper limit normal
* Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria

* Patients must not have had prior treatment with FUDR
* Patient must not be receiving any other investigational agents
* Patient must not have a diagnosis of Gilbert's disease
* Patient must not have a diagnosis of hepatic encephalopathy
* Patient must not have had prior external beam radiation to the liver
* Patient must not have a diagnosis of sclerosing cholangitis
* Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patient must not be pregnant or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No