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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Cetuximab — BIOLOGICAL
  Given IV
• Computed Tomography — PROCEDURE
  Undergo SPECT/CT and/or CT
• Floxuridine — DRUG
  Given via HAI pump
• Fluorouracil — DRUG
  Given IV
• Implantation — PROCEDURE
  Undergo surgery to place the HAI pump
• Intrahepatic Infusion Procedure — PROCEDURE
  Undergo HAI
• Irinotecan — DRUG
  Given IV
• Leucovorin — DRUG
  Given IV
• Oxaliplatin — DRUG
  Given IV
• Panitumumab — BIOLOGICAL
  Given IV
• Single Photon Emission Computed Tomography — PROCEDURE
  Undergo SPECT/CT

Study Details

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.

Key Dates

Start date

Oct 19, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2034

Study Design

Enrollment

408 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (HAI, floxuridine, standard chemotherapy)
  Patients undergo surgery to place the HAI pump, followed by SPECT/CT on study. Patients then receive floxuridine via the HAI pump on study. Patients also receive one of the following standard chemotherapy regimens per the treating physician: FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV and/or panitumumab IV on study. Patients also undergo CT scans throughout the trial.
• Active Comparator: Arm B (standard chemotherapy)
  Patients receive one of the following standard chemotherapy regimens per the treating physician: FOLFOXIRI, FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV, panitumumab IV, and/or bevacizumab IV on study. Patients also undergo CT scans throughout the trial.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years ]

Locations (60)

Find similar trials in Birmingham, AL

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