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

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.

Conditions

• Metastatic Colorectal Carcinoma
• Metastatic Malignant Neoplasm in the Liver
• Stage IV Colorectal Cancer AJCC v8
• Unresectable Colorectal Carcinoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

BIOLOGICAL

Cetuximab

Given IV

PROCEDURE

Computed Tomography

Undergo SPECT/CT and/or CT

DRUG

Floxuridine

Given via HAI pump

DRUG

Fluorouracil

Given IV

PROCEDURE

Implantation

Undergo surgery to place the HAI pump

PROCEDURE

Intrahepatic Infusion Procedure

Undergo HAI

DRUG

Irinotecan

Given IV

DRUG

Leucovorin

Given IV

DRUG

Oxaliplatin

Given IV

BIOLOGICAL

Panitumumab

Given IV

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• ECOG-ACRIN Cancer Research Group

  lead NETWORK

Principal Investigators

• Michael Lidsky · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-19

Primary Completion

2029-06-30

Completion

2034-06-30

FDA Drug

Yes

Countries

• United States

Study Locations