Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/1/2019 |
| Start Date: | February 5, 2019 |
| End Date: | April 2021 |
| Contact: | Gerald P. Wright, MD |
| Email: | paul.wright@spectrumhealth.org |
| Phone: | 616-486-6333 |
A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases
This is a single arm, phase II study without blinding. The purpose is to determine the impact
of hepatic artery infusion (HAI) FUDR on liver metastases from pancreatic adenocarcinoma.
Patients at Spectrum Health will receive standard of care chemotherapy. They will also
receive chemotherapy via a surgically placed HAI pump.
of hepatic artery infusion (HAI) FUDR on liver metastases from pancreatic adenocarcinoma.
Patients at Spectrum Health will receive standard of care chemotherapy. They will also
receive chemotherapy via a surgically placed HAI pump.
This study hypothesizes that the combination of 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 be followed for two years.
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 be followed for two years.
Inclusion Criteria:
- Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases
- Elevated 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 with RECIST read 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
- MELD score >20, using the variables of bilirubin, serum sodium, 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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