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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jonathan M Hernandez, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-24

Primary Completion

2025-11-13

Completion

2025-11-13

FDA Drug

Yes

Countries

• United States

Study Locations