NCT03366155

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: * Nearly 60% of patients with colorectal cancers will develop liver metastases over the course of their disease. * Of patients with metastatic colorectal cancer, the liver will be the sole site of recurrence or the survival-limiting site of disease for 20%. * Liver directed therapy, which has taken many forms over the last several decades, is a potential means to prolong survival for properly selected patients and delay progression at that site. * Hepatic artery infusion of floxuridine (FUDR) via an implantable hepatic artery infusion pump (HAIP) induces objective clinical response rates of nearly 50% in heavily pre-treated patients with metastatic colorectal cancer to the liver. * The identification of patients likely to respond to HAIP and those likely to suffer pumprelated adverse events is currently unknown, and has limited the wide-spread adoption of this otherwise well tolerated intervention. Objective: * To assess the safety of hepatic artery infusion therapy using the Medtronic pump with the Codman catheter. * To determine the response rate in patients with unresectable metastatic colorectal cancer treated with HAIP chemotherapy as measured by RECIST. Eligibility: * Histologically or cytologically confirmed colorectal adenocarcinoma metastatic to the liver. * Patients with liver metastases not amenable to resection to No Evidence of Disease (NED) in one stage. * Patients must have received systemic chemotherapy. * Age greater than or equal to 18 years. Design: \- Single arm, Phase II study of HAIP chemotherapy.

Conditions

• Colorectal Cancer
• Liver Metastases
• Colorectal Adenocarcinoma
• Colorectal Cancer With Hepatic Metastases
• Colorectal Carcinoma

Interventions

Type	Name	Description
DEVICE	Codman 3000 constant flow pump catheter	implanted Medtronic SynchroMed II Pump with codman 3000 Constant Flow Pump Catheter
DRUG	Panitumumab	6 mg/kg, IV
DRUG	FUDR-Dex	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)
DRUG	Oxaliplatin	85 mg/m2, IV
DRUG	5FU	2000 mg/m2, IV 46-hour infusion of 5-Fluorouracil + 400 mg/m2, IV of Leucovorin
DRUG	Irinotecan	150 mg/m2, IV
PROCEDURE	HAIP installation	HAI pump installation
DRUG	cetuximab	500 mg/m2, IV
DEVICE	Medtronic SynchroMed II Pump	implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter

Timeline

• Start date: 2019-06-24
• Primary completion: 2025-11-13
• Completion: 2025-11-13
• First posted: 2017-12-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study