RecruitingPhase 3NCT05863195

Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial


Sponsor

ECOG-ACRIN Cancer Research Group

Enrollment

408 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (the PUMP Trial) tests whether adding chemotherapy delivered directly into the liver through a surgically implanted pump — in addition to standard intravenous chemotherapy — is better than standard chemotherapy alone for people with colorectal cancer that has spread to the liver and cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have colorectal cancer that has spread only to the liver and cannot be surgically removed - You have completed 3–6 months of initial chemotherapy - You have no evidence of cancer spread outside the liver - You have adequate organ function **You may NOT be eligible if...** - Your cancer has spread beyond the liver to other parts of the body - You have not yet received any chemotherapy - You have severe liver disease or inadequate organ function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

DRUGIrinotecan

Given IV

DRUGLeucovorin

Given IV

DRUGOxaliplatin

Given IV

BIOLOGICALPanitumumab

Given IV

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT


Locations(39)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

IU Health North Hospital

Carmel, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

East White Plains, New York, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Parkland Memorial Hospital

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05863195


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