Hepatic Artery Infusional Floxuridine To Treat Pancreatic Cancer Liver Metastases

Study Overview

Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

This is a single arm, phase II study without blinding. The purpose is to determine the impact of hepatic artery infusion Floxuridine (FUDR) on liver metastases from pancreatic adenocarcinoma. Patients at Spectrum Health will receive standard of care chemotherapy. They will also receive chemotherapy via surgically placed hepatic artery infusion (HAI) pump.

This study hypothesizes that the combination of Floxuridine (FUDR), a type of chemotherapy, delivered via a hepatic artery infusion (HAI) pump, with standard of care systemic chemotherapy will lead to improved survival in the treatment of pancreatic cancer liver metastases. Patients will receive 6 cycles of FUDR and will be followed for two years.

Pancreatic Adenocarcinoma
Liver Metastases

DRUG: Floxuridine (FUDR)
DEVICE: Hepatic Artery Infusion Pump
DRUG: Heparinized Saline

2017-349

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-02-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-13
First Submitted that Met QC Criteria 2019-02-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-17
First Posted (ACTUAL) 2019-02-27	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Floxuridine (FUDR) via HAI pump Once enrolled, patients will undergo surgical placement of the HAI pump. This can be accomplished using minimally invasive or open techniques with an anticipated hospital stay of approximately 3-5 days. Prior to discharge from the hospital or at the first	DRUG: Floxuridine (FUDR) Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. DEVICE: Hepatic Artery Infusion Pump Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. DRUG: Heparinized Saline Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Floxuridine (FUDR) via HAI pump

Once enrolled, patients will undergo surgical placement of the HAI pump. This can be accomplished using minimally invasive or open techniques with an anticipated hospital stay of approximately 3-5 days. Prior to discharge from the hospital or at the first

DRUG: Floxuridine (FUDR)

Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications.

DEVICE: Hepatic Artery Infusion Pump

Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications.

DRUG: Heparinized Saline

Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications.

Primary Outcome Measures	Measure Description	Time Frame
Hepatic progression-free survival	The length of time from the start of trial therapy to the time when target liver lesions show progression or new lesions appear. (Determined by RECIST criteria: ≥20% growth in target lesions and/or appearance of new lesions).	1 year

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival	The length of time from diagnosis to death, measured as the proportion of patients surviving at specific time points (6, 12 and 18 months from diagnosis).	2 years
Progression-free survival at any site	The length of time from diagnosis to disease progression at any anatomical site (as determined by RECIST criteria) or death.	2 years
Rate of tumor response in the liver	Determined by RECIST criteria on imaging studies done every 3 months	2 years
EORTC Quality of Life Questionnaire	As measured by the EORTC Quality of Life Questionnaire Core 30 instrument	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases
Elevated Cancer Antigen 19-9 (CA19-9) at diagnosis (>37 U/mL)
Ages 18-75 years
Karnofsky performance status ≥70
Ability to undergo general anesthesia and HAI pump placement procedure
CT or MRI scan imaging of the abdomen demonstrating accessibility of the gastroduodenal artery within 2 months of enrollment
Received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging.

Primary tumor resected
Model for End Stage Liver Disease (MELD) score >20, using the variables of: Bilirubin, serum Sodium, International Normalized Ratio (INR), serum Creatinine, and Dialysis twice in the past week.
Greater than 60% liver parenchymal involvement by tumor
Evidence of peritoneal metastases
Current alcohol abuse
Pregnant or lactating women

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: G. Paul Wright, MD, Corewell Health

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record