Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases

Spectrum Health Hospitals

Status and phase: Active, not recruiting; Phase 2

Conditions: Pancreatic Adenocarcinoma; Liver Metastases

Treatments: Device: Hepatic Artery Infusion Pump; Drug: Heparinized Saline; Drug: Floxuridine (FUDR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03856658

2017-349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Floxuridine (FUDR) via HAI pump

Experimental group

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.

Treatment:

Drug: Floxuridine (FUDR)

Drug: Heparinized Saline

Device: Hepatic Artery Infusion Pump