Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
- Conditions
- Colorectal CancerColorectal Cancer With Hepatic MetastasesLiver MetastasesColorectal AdenocarcinomaColorectal Carcinoma
- Interventions
- Device: Codman 3000 constant flow pump catheterDrug: FUDR-DexDrug: 5FUProcedure: HAIP installationDevice: Medtronic SynchroMed II Pump
- Registration Number
- NCT03366155
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1/ Arm 1 Codman 3000 constant flow pump catheter HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 Panitumumab HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 FUDR-Dex HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 Oxaliplatin HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 5FU HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 cetuximab HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 Medtronic SynchroMed II Pump HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 HAIP installation HAIP chemotherapy + Systemic chemotherapy 1/ Arm 1 Irinotecan HAIP chemotherapy + Systemic chemotherapy
- Primary Outcome Measures
Name Time Method Response rate (RR) at progression The fraction of patients who experience a PR or CR using the study treatment
- Secondary Outcome Measures
Name Time Method Hepatic progression-free survival at progression The fraction of patients whose tumors in liver shrunk after therapy
Overall survival death Median amount of time subject survives after therapy
Extra-hepatic progression-free survival at progression The fraction of patients whose tumors outside liver shrunk after therapy
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States