Not recruiting

Study on Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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, a type of cancer that has spread from the colon or rectum to other parts of the body. The study is evaluating the effectiveness and safety of a combination treatment using two medications: cetuximab and irinotecan. Cetuximab is a type of medication known as a monoclonal antibody, which is designed to target specific proteins on cancer cells, while irinotecan is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

The purpose of this study is to compare the combination of cetuximab and irinotecan with other treatments chosen by doctors for patients who have already tried two other standard chemotherapy treatments without success. The study involves patients who have specific genetic characteristics, identified through a blood test, which may make them more likely to respond to this combination treatment. Participants will be randomly assigned to receive either the cetuximab and irinotecan combination or another treatment chosen by their doctor. The study will monitor the response of the cancer to the treatment, as well as any side effects experienced by the participants.

Throughout the study, participants will receive regular check-ups and tests to assess how well the treatment is working and to monitor their overall health. The study aims to provide valuable information on whether this combination of medications can be an effective third-line treatment option for patients with metastatic colorectal cancer. The trial is expected to continue until 2026, with the goal of improving treatment strategies for this challenging condition.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient will be randomly assigned to one of two groups. One group will receive a combination of cetuximab and irinotecan, while the other group will receive a treatment chosen by the investigator.
The patient will be informed about the specific treatment plan and any necessary preparations before starting the treatment.
Step 2
Treatment administration
For patients receiving cetuximab and irinotecan, the medications will be given as a solution through an intravenous infusion. This means the medicine will be delivered directly into the bloodstream through a vein.
The dosage, frequency, and duration of the treatment will be determined by the study protocol and communicated to the patient by the healthcare team.
Step 3
Monitoring and assessments
Throughout the study, the patient will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes physical examinations, blood tests, and imaging tests.
The healthcare team will evaluate the patient's response to the treatment and any side effects experienced.
Step 4
End of treatment
The treatment will continue until the patient experiences disease progression, unacceptable side effects, or decides to withdraw from the study.
At the end of the treatment, a final assessment will be conducted to evaluate the overall response to the therapy.
Step 5
Follow-up
After completing the treatment, the patient may be asked to attend follow-up visits to monitor their health and any long-term effects of the treatment.
These visits will help gather additional information about the treatment's impact and ensure the patient's well-being.

Who can join the trial?

13 criteria

Provide written informed consent before any study procedure is performed. This means you agree to participate after understanding the study details.
Have an ECOG performance status of 0-1. This is a scale that measures your ability to perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Have adequate bone marrow, kidney, and liver function. This means your blood tests show that your body is working well enough to handle the treatment.
No psychological, family, social, or geographical issues that might prevent you from following the study plan.
A life expectancy of more than 12 weeks, as determined by the study doctor.
Be a man or woman aged 18 years or older.
Have a confirmed diagnosis of metastatic colorectal cancer (mCRC) through a tissue test.
Have a RAS wild-type status from a tissue test before starting first-line treatment. This means certain genes (KRAS and NRAS) do not have mutations.
Have received two prior standard chemotherapy treatments for mCRC and not responded to them. These treatments must have included specific drugs, but not TAS-102 or regorafenib.
Have developed acquired resistance to certain anti-cancer drugs (cetuximab or panitumumab), meaning the cancer initially responded to these drugs but then stopped responding.
Have recovered from any side effects of the second-line treatment to a mild level, except for hair loss or nerve damage, which can be moderate.
Have a triple negative mutation status, meaning no specific mutations are found in certain genes (RAS, BRAF, and EGFR) in a blood test before starting the third-line treatment.
Have at least one measurable lesion, which is a tumor that can be measured on a scan according to specific criteria.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients who have received other treatments for their cancer within the last 4 weeks are not eligible.
Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, are excluded.
Patients with active infections, including HIV or hepatitis, cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients with a history of another type of cancer within the last 5 years, except for certain skin cancers, are excluded.
Patients with significant heart problems, such as a recent heart attack, are not eligible.
Patients who are unable to swallow pills or have digestive issues that affect medication absorption cannot participate.
Patients with a history of drug or alcohol abuse within the last year are excluded.
Patients who are participating in another clinical trial are not eligible.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Hospital Del Mar
Verified
Barcelona, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Cetuximab
is a medication used in cancer treatment. It works by targeting a specific protein on the surface of cancer cells, which can help slow down or stop the growth of the cancer. In this trial, cetuximab is being used to see if it can help treat patients with a specific type of colorectal cancer when used again after previous treatments.
Irinotecan
is another medication used to treat cancer. It works by interfering with the DNA of cancer cells, which can prevent them from growing and dividing. In this study, irinotecan is being used alongside cetuximab to see if this combination can be effective for patients with colorectal cancer who have already tried other treatments.

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 medicine for treating certain types of cancer, including metastatic colorectal cancer, and is well-documented in medical literature. The main therapeutic indication for cetuximab is to treat cancers that have specific genetic characteristics, such as being wild-type for RAS, BRAF, and EGFR-ECD genes. At the molecular level, cetuximab works by blocking a protein called the epidermal growth factor receptor (EGFR) on the surface of cancer cells, which helps to stop the cells from growing and dividing. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.
Irinotecan
Irinotecan is administered as an intravenous infusion, similar to cetuximab, and is used in the treatment of various cancers, including metastatic colorectal cancer. It is a well-established medication in the medical field and is often used in combination with other drugs. The main therapeutic indication for irinotecan is to treat advanced cancers that have not responded to other treatments. Irinotecan works at the molecular level by inhibiting an enzyme called topoisomerase I, which is necessary for DNA replication in cancer cells, thereby preventing them from multiplying. It is classified as a topoisomerase inhibitor, which is a type of chemotherapy drug.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and spread through the lymphatic system or bloodstream to distant organs. The disease often progresses through stages, starting from localized tumors to regional spread, and eventually to distant metastasis. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression.