Study on Using a Hepatic Artery Infusion Pump with Chemotherapy for Colorectal Cancer Spread to the Liver

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03366155

Provider View

This clinical trial is testing a new approach to treat colorectal cancer that has spread to the liver by using a pump to deliver chemotherapy directly to the liver, combined with standard chemotherapy. The study aims to see if this method is safe and effective in controlling the cancer.

Patient Parameters

Program Overview

The study is exploring a new treatment for colorectal cancer that has spread to the liver. It involves using a pump to deliver chemotherapy directly to the liver, which may help control the cancer more effectively. The pump releases the drug continuously over two weeks, and researchers want to see if this approach can improve outcomes for patients.

Description

Colorectal cancer often spreads to the liver, and this study is testing a new way to treat it. The treatment uses a pump to deliver chemotherapy directly to the liver, which may help control the cancer better than standard methods. The pump is placed under the skin and connected to the liver through a small tube. Patients will receive treatment in 28-day cycles, with regular check-ups and scans to monitor progress. The study aims to determine if this method is safe and effective in shrinking liver tumors and improving survival rates. Participants will be closely monitored for side effects and will have the option to have the pump removed after treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of colorectal cancer that has spread to the liver.
  • Must have liver tumors that can be measured by scans.
  • Must have tried standard chemotherapy treatments and either not responded, been intolerant, or still have cancer.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have adequate blood cell counts and organ function, including:
    • White blood cells over 3,000/mcL
    • Neutrophil count over 1,500/mcL
    • Platelet count over 90,000/mcL
    • Normal liver and kidney function as indicated by specific blood tests.
  • Must agree to use effective contraception during and after the study due to potential risks to unborn children.
  • Must have suitable liver artery anatomy for pump placement.
  • Must understand the study and agree to sign informed consent.
  • HIV-positive patients may participate after consulting with an HIV specialist.
  • Must agree to participate in a related tissue collection study.

Exclusion Criteria

  • Liver tumors that can be surgically removed in one operation.
  • Currently receiving other experimental treatments.
  • Cancer spread outside the liver and colon/rectum, except for small, stable lung tumors that can be removed if needed.
  • Recent surgery to remove cancer outside the liver with a short disease-free period.
  • Patients needing treatment with immune checkpoint inhibitors.
  • Uncontrolled health conditions that could interfere with the study.
  • Other active cancers within the last five years, except for certain skin or thyroid cancers.
  • Previous radiation treatment to the liver.
  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Active hepatitis B or C infections.
  • Allergic reactions to similar drugs used in the study.

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