NCT03366155View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

January 31, 2027

Conditions
Colorectal CancerLiver MetastasesColorectal AdenocarcinomaColorectal Cancer With Hepatic MetastasesColorectal 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

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT03366155 - Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver | Biotech Hunter | Biotech Hunter