Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

NCT03856658 | Active Not Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 2017-349
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Adenocarcinoma; Liver Metastases

Keywords

pancreatic cancer, pancreatic ductal carcinoma, liver metastases, HAI, hepatic artery infusion pump, FUDR, Floxuridine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  2 years

• Progression-free survival at any site

  2 years

• Rate of tumor response in the liver

  2 years

• EORTC Quality of Life Questionnaire

  2 years

Study Arms (1)

Floxuridine (FUDR) via HAI pump

EXPERIMENTAL

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 postoperative visit the pump is filled with FUDR according to the following equation: 0.12 mg/kg/d (using ideal body weight). This fill initiates day 1 of a 4-week cycle. The chemotherapy is infused by the pump continuously over 14 days. On day 15 (+/-4 days), the remaining chemotherapy is removed from the pump which is refilled with heparinized saline (30,000 units). This remains for an additional 2 weeks until the pump is refilled with FUDR at the start of the next cycle. Treatment is continued for a maximum of 6 cycles or as limited by toxicity. This regimen has been utilized with an acceptable safety profile in the setting of colorectal liver metastases.

Drug: Floxuridine (FUDR); Device: Hepatic Artery Infusion Pump; Drug: Heparinized Saline

Interventions

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.

Also known as: FUDR

Floxuridine (FUDR) via HAI pump

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.

Also known as: HAI pump, Medtronic pump

Floxuridine (FUDR) via HAI 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.

Floxuridine (FUDR) via HAI pump

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Carcinoma, Pancreatic Ductal

Interventions

Floxuridine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• G. Paul Wright, MD

  Corewell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncology and Hepatopancreaticobiliary Surgeon

Model Details: Single arm study without blinding

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: February 5, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)