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Study on Cetuximab and Drug Combination for Patients with Metastatic Colorectal Cancer

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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 metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The study aims to evaluate the effectiveness of continuing treatment with a medication called cetuximab beyond the first line of treatment. Cetuximab is a drug used to target specific cancer cells. The trial will compare the use of cetuximab with another medication called bevacizumab, which is also used to treat cancer by inhibiting the growth of blood vessels that supply the tumor.

Participants in the study will receive a combination of chemotherapy drugs, which include fluorouracil, oxaliplatin, calcium levofolinate, and irinotecan. These drugs are administered through an infusion, which means they are given directly into the bloodstream. The study will last for a period of up to 12 months, during which the participants will be monitored to assess the response of their cancer to the treatment. The goal is to determine which combination of drugs is more effective in treating metastatic colorectal cancer.

The trial will involve regular imaging tests to evaluate the size and spread of the cancer. These tests will be reviewed by specialists who are not aware of which treatment the participants are receiving, ensuring an unbiased assessment. The study will also monitor the safety of the drugs by checking for any side effects or changes in health. The results of this trial could help improve treatment options for patients with metastatic colorectal cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the clinical trial, the treatment begins with the administration of medications through an infusion. This involves receiving the medication directly into the bloodstream through a vein.
The medications used in this trial include fluorouracil, oxaliplatin, calcium levofolinate, cetuximab, irinotecan, and bevacizumab. Each of these medications is administered via infusion.
Step 2
Medication schedule
The specific schedule for medication administration will be provided by the healthcare team. It is important to follow the schedule as instructed to ensure the effectiveness of the treatment.
The frequency and dosage of each medication will be determined based on the treatment plan designed for the trial.
Step 3
Monitoring and assessments
Throughout the trial, regular monitoring and assessments will be conducted to evaluate the response to the treatment. This includes imaging tests, which will be reviewed by an external radiology department.
The assessments will help determine the Objective Response Rate (ORR), which measures how well the cancer responds to the treatment.
Step 4
Progress evaluation
The trial will also evaluate Progression Free Survival (PFS), which is the time during and after the treatment that the patient lives with the disease without it getting worse.
Additionally, Overall Survival (OS) will be assessed, which is the time from enrollment in the trial to death from any cause.
Step 5
Safety monitoring
The safety of the medications will be closely monitored throughout the trial. This includes tracking any side effects or adverse events that may occur.
Regular clinical laboratory assessments, vital signs checks, physical examinations, and ECG (electrocardiogram) parameters will be part of the safety monitoring process.
Step 6
End of treatment
The trial is estimated to end by May 1, 2030. The duration of participation in the trial will depend on individual response to the treatment and other factors as determined by the healthcare team.
Upon completion of the trial, further instructions and follow-up care will be provided by the healthcare team.

Who can join the trial?

14 criteria

Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
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Must have adequate bone marrow, liver, and kidney function, which will be checked within 14 days before starting the study treatment. This includes:
- Bone marrow function: Enough white blood cells, hemoglobin, and platelets.
- Liver function: Normal levels of bilirubin and liver enzymes, unless the liver is affected by the tumor.
- Kidney function: Normal creatinine levels or sufficient kidney clearance.
- If female and able to have children, must have a negative pregnancy test within 7 days before starting the study treatment.
- If female and able to have children, or if male, must agree to use effective birth control during the study and for at least 3 months after the last dose of study treatment.
- Must have signed an informed consent form before any screening procedures.
- Must have a diagnosis of metastatic disease, meaning the cancer has spread to other parts of the body.
- Must have shown a significant response or stable disease for at least 6 months to a first-line therapy that included an anti-EGFR drug.
- Must have experienced progression after the first-line therapy.
- Must have a specific genetic profile, including RAS and BRAF wild-type status, which means certain genes are not mutated.
- Must have measurable disease according to specific criteria used to evaluate tumors.
- Must be 18 years of age or older.
- Must have an ECOG Performance Status of 0-1, which indicates the level of daily functioning and ability to care for oneself.

Who cannot join the trial?

7 criteria

Patients who do not have metastatic colorectal cancer cannot participate. This means the cancer has spread from the colon or rectum to other parts of the body.
Patients who have not been selected based on specific molecular characteristics of their cancer cannot participate. This refers to certain genetic features of the cancer cells.
Patients who are not suitable for a second line treatment cannot participate. This means they have not previously received a different treatment for their cancer.
Patients who are not able to undergo chemotherapy doublet cannot participate. This is a combination of two chemotherapy drugs used together.
Patients who cannot receive cetuximab or bevacizumab cannot participate. These are specific drugs used to treat cancer.
Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
Patients who are not able to have their imaging assessed by an external radiology department cannot participate. This means their scans need to be reviewed by specialists outside the main study site.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Cetuximab
is a medication used in this clinical trial to treat patients with a specific type of colorectal cancer. It works by targeting and blocking a protein on the surface of cancer cells, which can slow down or stop the growth of the cancer. In this study, cetuximab is being used to see if continuing its use after the cancer has progressed can help improve patient outcomes.
Bevacizumab
is another medication being tested in this trial. It is used to treat various types of cancer by inhibiting the growth of blood vessels that supply nutrients to tumors. By blocking these blood vessels, bevacizumab can help to starve the cancer cells and slow their growth. In this study, it is being compared to cetuximab to see which is more effective when combined with chemotherapy for treating colorectal cancer.

What is already known about the treatment

Cetuximab
Cetuximab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently used in the treatment of metastatic colorectal cancer, particularly in patients whose cancer has specific molecular characteristics. Cetuximab works by targeting a protein on the surface of cancer cells called the epidermal growth factor receptor (EGFR), blocking signals that tell the cancer cells to grow and divide. It is classified as a monoclonal antibody, a type of targeted cancer therapy.
Bevacizumab
Bevacizumab is also administered as an intravenous infusion. It is used in the treatment of various cancers, including metastatic colorectal cancer. Bevacizumab works by inhibiting a protein called vascular endothelial growth factor (VEGF), which helps tumors form new blood vessels to get nutrients and grow. By blocking VEGF, bevacizumab can slow or stop the growth of cancer. It is classified as an angiogenesis inhibitor, a type of targeted therapy that focuses on cutting off the blood supply to tumors.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. It typically begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the disease progresses, cancer cells can invade nearby tissues and spread through the bloodstream or lymphatic system to distant organs, most commonly the liver and lungs. The progression of the disease can lead to symptoms such as changes in bowel habits, abdominal pain, and weight loss. The spread of cancer to other organs can cause additional symptoms depending on the affected area. The disease is often monitored through imaging studies to assess the extent of spread and response to treatment.