Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
University of Kentucky
Lexington, Kentucky, United States
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
Time frame: approximately 4 weeks
30-day Postoperative Serious Adverse Events Related to Pump Implantation
Tabulation of CTCAE serious adverse events attributed to pump implantation
Time frame: 30 days
30-day Catheter Malfunction Due to Tubing Disconnect
Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.
Time frame: 30 days
30-day Catheter Malfunction Due to Inability to Access Pump
Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.
Time frame: 30 days
Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.
Time frame: Approximately 4 weeks
Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.
Time frame: Immediate, determined at screening visit
Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.
Time frame: Approximately 6 months
Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.
Time frame: 6 months
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.
Time frame: 3 months
Overall Response Rate at 6 Months
RECIST v1.1 will be used to assess overall response rate at 6 months.
Time frame: 6 months
Percent of Patients Who Are Downstaged and Undergo Surgery
The percent of patients who are downstaged and undergo surgery will be tabulated.
Time frame: 6 months
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.
Time frame: 6 months
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