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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor: National Cancer Institute (NCI)
Study ID: NCT03366155
Phase: PHASE2
Status: Completed

Conditions

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

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Codman 3000 constant flow pump catheter — DEVICE
Implanted Medtronic SynchroMed II Pump with codman 3000 Constant Flow Pump Catheter
Panitumumab — DRUG
6 mg/kg, intravenous (IV)
FUDR-Dex — DRUG
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 — DRUG
85 mg/m\^2, intravenous (IV)
5FU — DRUG
2000 mg/m\^2, intravenous (IV) 46-hour infusion of 5-Fluorouracil + 400 mg/m\^2, IV of Leucovorin
Irinotecan — DRUG
150 mg/m\^2, intravenous (IV)
HAIP installation — PROCEDURE
Hepatic Artery Infusion (HAI) pump installation
cetuximab — DRUG
500 mg/m\^2, intravenous (IV)
Medtronic SynchroMed II Pump — DEVICE
Implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter
Floxuridine — DRUG
Floxuridine 0.12 mg/kg X pump volume X pump flow rate
Dexamethasone — DRUG
1 mg/day X pump volume (30) X pump flow rate
EKG — DIAGNOSTIC_TEST
Screening and baseline.
CT C/A/P — DIAGNOSTIC_TEST
Screening, baseline and Cycle 1. One cycle is 28 (+/- 2 days).
CT Angiogram (abdomen) — DIAGNOSTIC_TEST
Screening
Tumor and normal liver biopsy — PROCEDURE
For research: During surgery to install pump, time of progression per principal investigator discretion if safe, and end of treatment.
Leucovorin — DRUG
400 mg/m\^2, intravenous (IV), (Day15, Day1)

Study Details

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.