Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 5, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Pancreatic AdenocarcinomaLiver Metastases
Interventions
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.

Trial Locations (1)

49503

Spectrum Health, Grand Rapids

All Listed Sponsors
lead

Spectrum Health Hospitals

OTHER

NCT03856658 - Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases | Biotech Hunter | Biotech Hunter