Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Adenocarcinoma
- Colorectal Cancer
- Colorectal Cancer With Hepatic Metastases
- Colorectal Carcinoma
- Liver Metastases
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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 pretreated 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.
Tracking Information
- NCT #
- NCT03366155
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jonathan M Hernandez, M.D. National Cancer Institute (NCI)
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