A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial
ECOG-ACRIN Cancer Research Group
Summary
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
Description
PRIMARY OBJECTIVE: I. To determine if patients with persistently unresectable colorectal liver metastases (CRLM) after treatment with first-line chemotherapy have improved overall survival (OS) with hepatic arterial infusion (HAI) and systemic chemotherapy versus systemic chemotherapy alone. SECONDARY OBJECTIVES: I. To determine whether there is a direct association between hepatic progression free survival (hPFS) and overall survival (OS) when patients are treated with HAI combined with systemic chemotherapy for unresectable CRLM. II To determine the impact on progression free survival (o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC). * Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes). * NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study. * Patient may have calcified pulmonary nodules, and/or =\< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =\…
Interventions
- BiologicalBevacizumab
Given IV
- BiologicalCetuximab
Given IV
- ProcedureComputed Tomography
Undergo SPECT/CT and/or CT
- DrugFloxuridine
Given via HAI pump
- DrugFluorouracil
Given IV
- ProcedureImplantation
Undergo surgery to place the HAI pump
- ProcedureIntrahepatic Infusion Procedure
Undergo HAI
Locations (39)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- UCHealth University of Colorado HospitalAurora, Colorado
- UM Sylvester Comprehensive Cancer Center at AventuraAventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at HollywoodHollywood, Florida