Status:
ACTIVE_NOT_RECRUITING
Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
Lead Sponsor:
Corewell Health West
Conditions:
Pancreatic Adenocarcinoma
Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03856658
Start Date
February 5 2019
End Date
December 1 2025
Last Update
June 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Spectrum Health
Grand Rapids, Michigan, United States, 49503