Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

Sponsor: Spectrum Health Hospitals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03856658

Patient View

This phase II study evaluates the impact of Floxuridine (FUDR) via hepatic artery infusion (HAI) pump combined with standard chemotherapy on pancreatic cancer liver metastases. Eligible patients, aged 18-75 with biopsy-proven adenocarcinoma and stable tumor markers, will undergo HAI pump placement. FUDR is administered in 28-day cycles for 6 months, alternating with heparinized saline.

Patient Parameters

Program Overview

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.

Eligibility 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

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