Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
- Conditions
- Pancreatic AdenocarcinomaLiver Metastases
- Interventions
- Registration Number
- NCT03856658
- Lead Sponsor
- Spectrum Health Hospitals
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Floxuridine (FUDR) via HAI pump Floxuridine (FUDR) 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. Floxuridine (FUDR) via HAI pump Heparinized Saline 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. Floxuridine (FUDR) via HAI pump Hepatic Artery Infusion Pump 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
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
Trial Locations
- Locations (1)
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States