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Study of Irinotecan with FOLFOX and Bevacizumab for Patients with Unresectable Colorectal Cancer Metastases

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for patients with unresectable colorectal peritoneal metastases, which is a condition where cancer from the colon or rectum has spread to the lining of the abdomen and cannot be removed with surgery. The treatment being tested involves the use of irinotecan hydrochloride, a medication that is typically used in chemotherapy, but in this study, it is administered directly into the abdominal cavity. This method is known as intraperitoneal infusion. The study also includes the use of a combination of other chemotherapy drugs known as FOLFOX and a medication called bevacizumab.

The purpose of the study is to explore how effective this treatment combination is in improving the survival of patients with this type of cancer. Participants in the study will receive the treatment over a period of time, and their health will be monitored to see how the cancer responds. The study aims to determine if this approach can help control the cancer and improve the quality of life for patients.

Throughout the study, patients will receive regular check-ups and assessments to track their progress and any side effects they may experience. The study is designed to gather important information that could lead to better treatment options for people with unresectable colorectal peritoneal metastases in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed through written informed consent. Eligibility is based on specific criteria, including a confirmed diagnosis of colorectal cancer with unresectable peritoneal metastases and a performance score indicating good health.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of irinotecan hydrochloride at a dose of 75 mg. This medication is given through a method called intraperitoneal use, which means it is delivered directly into the abdominal cavity.

    In addition to irinotecan, the treatment includes a combination of other medications known as FOLFOX and bevacizumab. FOLFOX is a chemotherapy regimen that includes folinic acid, fluorouracil, and oxaliplatin.

  3. Step 3

    Treatment schedule

    The treatment is administered in cycles. Each cycle includes the administration of the medications as per the prescribed regimen. The frequency and duration of each cycle are determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the patient's response to treatment and overall health. This includes medical evaluations and imaging tests to track the progress of the disease.

    The primary goal is to evaluate the anti-tumor activity of the treatment, focusing on overall survival from the time of diagnosis of peritoneal metastases.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 2025. Upon completion, final assessments are conducted to determine the outcomes of the treatment and its impact on the patient's health.

Who can join the trial?

6 criteria

  • The patient must have **colorectal cancer** that has been confirmed by a test called a **histology**.
  • The patient must have **unresectable colorectal peritoneal metastases**, which means the cancer has spread to the lining of the abdomen and cannot be removed by surgery. This must be confirmed by imaging tests or other medical evaluations.
  • The patient must have a **WHO performance score** of 0-1, which indicates they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • The patient must have a life expectancy of more than 3 months.
  • The patient must be 18 years old or older.
  • The patient must provide **written informed consent**, which means they agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer that are not related to colorectal cancer.
  • Patients who have had previous treatments that might interfere with the study.
  • Patients with serious health conditions that could make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have allergies to the medications used in the study.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • Irinotecan

    is a medication used in this trial to treat colorectal cancer that has spread to the lining of the abdomen. It is administered directly into the abdominal cavity to target cancer cells more effectively. The goal is to see if this method can improve survival rates for patients with this type of cancer.

  • FOLFOX

    is a combination of chemotherapy drugs used to treat colorectal cancer. It includes a mix of medications that work together to stop cancer cells from growing and dividing. In this trial, FOLFOX is used alongside other treatments to see if it can help improve patient outcomes.

  • Bevacizumab

    is a medication that helps prevent the growth of new blood vessels that tumors need to grow. By blocking this process, bevacizumab can help slow down or stop the growth of cancer. In this trial, it is used in combination with other treatments to see if it can enhance their effectiveness in treating colorectal cancer.

What is already known about the treatment

  • Irinotecan

    This medication is administered intraperitoneally, meaning it is delivered directly into the abdominal cavity. It is currently being studied in clinical trials for its effectiveness in treating patients with colorectal cancer that has spread to the peritoneum and cannot be surgically removed. Irinotecan is primarily used for its anti-cancer properties, working by inhibiting an enzyme called topoisomerase I, which is essential for DNA replication in cancer cells, thereby preventing their growth and division. It is classified as a topoisomerase inhibitor in pharmacology.

  • FOLFOX

    This is a combination chemotherapy regimen that is administered intravenously. It is widely used in the treatment of colorectal cancer, including cases where the cancer has metastasized to other parts of the body. FOLFOX consists of folinic acid, fluorouracil, and oxaliplatin, which work together to disrupt the DNA of cancer cells, inhibiting their ability to multiply. It is classified under antineoplastic agents, specifically as a combination chemotherapy protocol.

  • Bevacizumab

    This medication is given intravenously and is used in the treatment of various cancers, including colorectal cancer with metastases. Bevacizumab is a monoclonal antibody that targets and inhibits vascular endothelial growth factor (VEGF), a protein that promotes the growth of new blood vessels. By blocking VEGF, bevacizumab helps to starve tumors of the blood supply they need to grow. It is classified as an angiogenesis inhibitor in pharmacology.

Investigated diseases

Colorectal Cancer with Peritoneal Metastases – This condition occurs when cancer originating in the colon or rectum spreads to the peritoneum, the lining of the abdominal cavity. The metastases are considered irresectable, meaning they cannot be surgically removed. As the disease progresses, cancer cells continue to grow and spread within the peritoneal cavity. This can lead to symptoms such as abdominal pain, bloating, and changes in bowel habits. The progression of the disease can vary, but it typically involves the gradual worsening of symptoms as the cancer advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517152-34-00Estimated enrolment85 patientsSponsorCatharina Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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