Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Treatments: Floxuridine

Criteria

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