Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03856658

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Pancreatic Adenocarcinoma Adenocarcinoma Carcinoma Carcinoma, Ductal Carcinoma, Pancreatic Ductal Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Metastases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Corewell Health West

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Floxuridine (FUDR)

Drug

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. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Other names: FUDR

Hepatic Artery Infusion Pump

Device

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. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. The primary tumor will be resected or ablated with irreversible electroporation at the time of HAI pump placement. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Other names: HAI pump, Medtronic pump

Heparinized Saline

Drug

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. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.

Primary outcomes

  1. Hepatic progression-free survival

    Time frame: 1 year

    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).

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

    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. Progression-free survival at any site

    Time frame: 2 years

    The length of time from diagnosis to disease progression at any anatomical site (as determined by RECIST criteria) or death.

  3. Rate of tumor response in the liver

    Time frame: 2 years

    Determined by RECIST criteria on imaging studies done every 3 months

  4. EORTC Quality of Life Questionnaire

    Time frame: 2 years

    As measured by the EORTC Quality of Life Questionnaire Core 30 instrument

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2019
Registry last updated
Jul 16, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.