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Study on Cetuximab, Irinotecan, and Fluorouracil for First-Line Treatment in Patients with Advanced Colorectal Cancer

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 the effectiveness of a treatment for patients with advanced Colorectal Cancer. The treatment being tested includes a combination of medications: Cetuximab, Irinotecan, and Fluorouracil. These medications are used together as a first-line treatment, which means they are the initial treatment given for this type of cancer. The study is specifically looking at patients whose cancer has spread to other parts of the body, known as metastatic colorectal cancer, and who have certain genetic characteristics, such as being RAS wild-type and having the FcγRIIIA V/V genotype.

The purpose of the study is to evaluate whether this combination of medications is effective in treating this specific group of patients. Participants in the study will receive the treatment through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor the patients over a period of time to see how well the treatment works and to observe any side effects. The study will also look at how long the treatment remains effective and the overall survival of the patients.

Throughout the study, the effectiveness of the treatment will be assessed using specific criteria to measure the size and growth of the cancer. The study will also track the duration of the patients' response to the treatment, the time until the cancer progresses, and any toxic effects experienced. The study aims to provide valuable information on the potential benefits of this treatment combination for patients with advanced colorectal cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.
Step 2
Treatment initiation
The treatment begins with the administration of the medication regimen known as FOLFIRI combined with cetuximab. This involves receiving the medications through an infusion, which is a method of delivering drugs directly into the bloodstream over a set period.
Step 3
Medication details
The medications include cetuximab, folinic acid, fluorouracil, and irinotecan. Each is administered via infusion. The specific dosage and frequency are determined by the medical team based on individual patient needs and study protocols.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring is conducted to assess the patient's response to the treatment. This includes physical examinations, blood tests, and imaging studies to evaluate the effectiveness and any side effects of the treatment.
Step 5
Response evaluation
The patient's response to the treatment is evaluated using criteria known as RECIST version 1.1, which helps in measuring changes in tumor size and progression.
Step 6
Completion of treatment
The treatment continues until the study's end date or until the medical team decides it is appropriate to stop. The estimated end date for the trial is May 20, 2026.
Step 7
Follow-up
After completing the treatment, follow-up visits may be scheduled to monitor long-term health and any lasting effects of the treatment.

Who can join the trial?

11 criteria

Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
Must be receiving FOLFIRI combined with Cetuximab as the first treatment for metastatic colorectal cancer. This means the cancer has spread to other parts of the body.
Must have a RAS wild-type tumor. This means the cancer does not have certain genetic mutations.
Must have the FcγRIIIa-158V/V genotype. This is a specific genetic characteristic.
Must be at Stage IV of cancer, indicating advanced cancer that has spread to other parts of the body.
If applicable, must have a negative pregnancy test to ensure they are not pregnant.
Must be younger than 75 years old.
Must have at least one measurable lesion, which is a tumor that can be measured in size, according to specific criteria called RECIST v1.1.
Must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Must have a life expectancy of more than 3 months.
Must provide written informed consent, which means they agree to participate in the study after being informed about it.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than colorectal cancer cannot participate.
Patients who do not have metastatic colorectal cancer cannot participate. This means the cancer has spread to other parts of the body.
Patients who do not have a specific genetic type called RAS wild-type cannot participate. This refers to a normal version of a gene that is not mutated.
Patients who do not have a specific genetic marker called FcγRIIIA V/V cannot participate. This is a specific version of a protein on the surface of certain immune cells.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie
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Pozzuoli, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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Naples, Italy

Trial locations

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Investigated drugs

Cetuximab
is a medication used in this trial to help treat advanced colorectal cancer. It works by targeting a specific protein on the surface of cancer cells, which can slow down or stop the growth of the cancer. This medication is often used in combination with other cancer treatments to improve their effectiveness.
Irinotecan
is another medication involved in the trial. It is a type of chemotherapy that helps to kill cancer cells or stop them from growing and dividing. Irinotecan is used to treat colorectal cancer and is often given in combination with other drugs to enhance its cancer-fighting effects.
Fluorouracil
is a chemotherapy drug used in this study to treat colorectal cancer. It works by interfering with the cancer cells' ability to grow and multiply. This medication is commonly used in combination with other treatments to increase its effectiveness in fighting cancer.

What is already known about the treatment

Cetuximab
Cetuximab is administered intravenously, meaning it is given through a vein, usually in a hospital or clinic setting. It is currently used in medicine as a treatment for certain types of cancer, particularly advanced colorectal cancer. The main therapeutic indication for cetuximab is for patients with metastatic colorectal cancer who have specific genetic markers, such as RAS wild-type. At the molecular level, cetuximab works by blocking a protein called the epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. It is classified as a monoclonal antibody, a type of targeted cancer therapy.
Irinotecan
Irinotecan is administered intravenously, typically in a clinical setting, as part of a chemotherapy regimen. It is well-established in medical literature as a treatment for colorectal cancer, especially in advanced stages. The main therapeutic use of irinotecan is for patients with metastatic colorectal cancer. Its mechanism of action involves inhibiting an enzyme called topoisomerase I, which is necessary for DNA replication in cancer cells, thereby preventing their growth and division. Irinotecan is classified as a topoisomerase inhibitor, a type of chemotherapy drug.
Fluorouracil
Fluorouracil is given intravenously, often in a hospital or clinic, as part of a chemotherapy treatment plan. It is widely recognized in medicine for its role in treating various cancers, including colorectal cancer. The primary therapeutic indication for fluorouracil is in patients with advanced colorectal cancer. At the molecular level, it works by interfering with the synthesis of DNA and RNA in cancer cells, which inhibits their growth and proliferation. Fluorouracil is classified as an antimetabolite, a type of chemotherapy agent.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. The disease is often associated with changes in bowel habits, blood in the stool, and abdominal discomfort.