Pancreatic Adenocarcinoma, Liver Metastases
Conditions
Keywords
pancreatic cancer, pancreatic ductal carcinoma, liver metastases, HAI, hepatic artery infusion pump, FUDR, Floxuridine
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 at Spectrum Health will receive standard of care chemotherapy. They will also receive chemotherapy via surgically placed hepatic artery infusion (HAI) pump.
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 improved survival in the treatment of pancreatic cancer liver metastases. Patients will receive 6 cycles of FUDR and will be followed for two years.
Interventions
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.
DEVICEHepatic 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.
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.
Sponsors
Corewell Health West
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study without blinding
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic progression-free survival | 1 year | The length of time from the start of trial therapy to the time when target liver lesions show progression or new lesions appear. (Determined by RECIST criteria: ≥20% growth in target lesions and/or appearance of new lesions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | The length of time from diagnosis to death, measured as the proportion of patients surviving at specific time points (6, 12 and 18 months from diagnosis). |
| Progression-free survival at any site | 2 years | The length of time from diagnosis to disease progression at any anatomical site (as determined by RECIST criteria) or death. |
| Rate of tumor response in the liver | 2 years | Determined by RECIST criteria on imaging studies done every 3 months |
| EORTC Quality of Life Questionnaire | 2 years | As measured by the EORTC Quality of Life Questionnaire Core 30 instrument |
Countries
United States
Outcome results
None listed