Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03856658
• Other study ID #: 2017-349
• Status: Recruiting
• Phase: Phase 2
• Start date: February 5, 2019
• Est. completion date: April 2026

Study information

• Verified date: January 2024
• Source: Spectrum Health Hospitals
• Contact: G. Paul Wright, MD
• Phone: 616-486-6333
• Email: paul.wright[@]spectrumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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. 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.

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. 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.

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. 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.

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Rate of tumor response in the liver	Determined by RECIST criteria on imaging studies done every 3 months	2 years
Secondary	EORTC Quality of Life Questionnaire	As measured by the EORTC Quality of Life Questionnaire Core 30 instrument	2 years