Clinical trial · Interventional
Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases
NCT03856658CI-TRIAL-00118144active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Floxuridine (FUDR) | Drug | — | UNRESOLVED |
| Heparinized Saline | Drug | — | UNRESOLVED |
| Hepatic Artery Infusion Pump | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Floxuridine (FUDR) via HAI pump
- description
- Once enrolled, patients will undergo surgical placement of the HAI pump. This can be accomplished using minimally invasive or open techniques with an anticipated hospital stay of approximately 3-5 days. Prior to discharge from the hospital or at the first postoperative visit the pump is filled with FUDR according to the following equation: 0.12 mg/kg/d (using ideal body weight). This fill initiates day 1 of a 4-week cycle. The chemotherapy is infused by the pump continuously over 14 days. On day 15 (+/-4 days), the remaining chemotherapy is removed from the pump which is refilled with heparinized saline (30,000 units). This remains for an additional 2 weeks until the pump is refilled with FUDR at the start of the next cycle. Treatment is continued for a maximum of 6 cycles or as limited by toxicity. This regimen has been utilized with an acceptable safety profile in the setting of colorectal liver metastases.
- interventionNames
- Drug: Floxuridine (FUDR)
- Device: Hepatic Artery Infusion Pump
- Drug: Heparinized Saline
Primary outcomes (1)
- measure
- Hepatic progression-free survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.