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Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
Sponsor: National Cancer Institute (NCI)
Summary
Background: Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person's body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver. Objective: To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver. Eligibility: Adults at least 18 years old with colorectal metastases to the liver Design: Participants will be screened with: Medical history Physical exam Heart, blood, and urine tests Scans Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it. Participants will get treatment in 28-day cycles. Every Day 1, they will have physical exam, symptom review, and blood tests. Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port. Every 12 weeks, they will have a scan. Tissue samples may be taken during the study. When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing.
Official title: A Single-Arm Phase II Study of Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2019-06-24
Completion Date
2025-11-13
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Codman 3000 constant flow pump catheter
Implanted Medtronic SynchroMed II Pump with codman 3000 Constant Flow Pump Catheter
Panitumumab
6 mg/kg, intravenous (IV)
FUDR-Dex
Hepatic Artery Infusion Pump (HAIP) will be filled with mixture of Floxuridine and Dexamethasone. Pump will perfuse drugs to liver for 14 days. Floxuridine (0.12 mg/kg X pump volume X pump flow rate), Dexamethasone (1 mg/day X pump volume (30) X pump flow rate)
Oxaliplatin
85 mg/m\^2, intravenous (IV)
5FU
2000 mg/m\^2, intravenous (IV) 46-hour infusion of 5-Fluorouracil + 400 mg/m\^2, IV of Leucovorin
Irinotecan
150 mg/m\^2, intravenous (IV)
HAIP installation
Hepatic Artery Infusion (HAI) pump installation
cetuximab
500 mg/m\^2, intravenous (IV)
Medtronic SynchroMed II Pump
Implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter
Floxuridine
Floxuridine 0.12 mg/kg X pump volume X pump flow rate
Dexamethasone
1 mg/day X pump volume (30) X pump flow rate
EKG
Screening and baseline.
CT C/A/P
Screening, baseline and Cycle 1. One cycle is 28 (+/- 2 days).
CT Angiogram (abdomen)
Screening
Tumor and normal liver biopsy
For research: During surgery to install pump, time of progression per principal investigator discretion if safe, and end of treatment.
Leucovorin
400 mg/m\^2, intravenous (IV), (Day15, Day1)
Locations (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States