Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

Last updated: June 13, 2025
Sponsor: Spectrum Health Hospitals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Pancreatic Cancer

Digestive System Neoplasms

Adenocarcinoma

Treatment

Heparinized Saline

Hepatic Artery Infusion Pump

Floxuridine (FUDR)

Clinical Study ID

NCT03856658
2017-349
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thegastroduodenal artery within 2 months of enrollment

  • Received a minimum of 2 months of systemic chemotherapy with stable tumor markersand imaging.

Exclusion

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, andDialysis twice in the past week.

  • Greater than 60% liver parenchymal involvement by tumor

  • Evidence of peritoneal metastases

  • Current alcohol abuse

  • Pregnant or lactating women

Study Design

Total Participants: 14
Treatment Group(s): 3
Primary Treatment: Heparinized Saline
Phase: 2
Study Start date:
February 05, 2019
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

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