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Study on Intermittent vs. Continuous Panitumumab and FOLFIRI for Patients with Unresectable Left-Sided 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 a type of cancer called metastatic colorectal cancer, specifically when it is located on the left side of the colon and cannot be surgically removed. The cancer must also be of a specific genetic type known as RAS/B-RAF wild-type. The study is investigating a treatment that combines a medication called Panitumumab with a chemotherapy regimen known as FOLFIRI. Panitumumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to determine if giving Panitumumab and FOLFIRI in an intermittent manner (with breaks) is as effective as giving it continuously (without breaks) for patients who have not received any prior treatment for their metastatic colorectal cancer. The study also aims to see if the intermittent treatment can improve safety, tolerability, and quality of life compared to the continuous treatment. Participants will be randomly assigned to one of the two treatment groups and will receive the treatment until their cancer progresses or they experience unacceptable side effects.

Throughout the study, researchers will monitor the effectiveness and safety of the treatments by looking at various factors, such as how long patients live without their cancer getting worse and the overall survival time. They will also assess the quality of life of participants using specific questionnaires. Additionally, the study will explore potential biomarkers, which are biological indicators that might help predict how well a patient will respond to the treatment. Blood samples and, when available, tissue samples from tumors will be collected to help with this research.

The research process

The trial runs in 4 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 treatment groups: intermittent or continuous treatment.
The study involves the use of panitumumab in combination with a chemotherapy regimen known as FOLFIRI.
Step 2
Treatment administration
The treatment consists of panitumumab, administered as an infusion. The specific dosage and frequency will depend on the group assignment.
In the continuous treatment group, the medication is given without breaks until disease progression or unacceptable side effects occur.
In the intermittent treatment group, the medication is given in cycles with planned breaks, also until disease progression or unacceptable side effects occur.
Step 3
Monitoring and assessments
Regular monitoring will occur to assess the effectiveness of the treatment and to check for any side effects.
Assessments will include imaging tests to measure tumor response, blood tests, and questionnaires to evaluate quality of life.
Step 4
End of treatment
The treatment will continue until the disease progresses, side effects become unacceptable, or the patient decides to stop.
After the treatment ends, follow-up assessments will be conducted to monitor the patient's health and any long-term effects of the treatment.

Who can join the trial?

14 criteria

Provide written informed consent to participate in the study and related research.
Have known activity of an enzyme called dihydropyrimidine dehydrogenase (DPYD). Testing for another enzyme, UGT1A1, is recommended but not required.
Have adequate bone marrow function, which means having enough white blood cells, platelets, and hemoglobin in the blood.
Have adequate liver function, meaning certain liver tests must be within normal limits.
Have adequate kidney function, which involves having normal levels of a substance called creatinine in the blood or a certain level of kidney filtration.
Have normal levels of electrolytes like magnesium, calcium, sodium, and potassium in the blood.
Have a confirmed diagnosis of left-sided metastatic colorectal cancer (mCRC).
Have a specific type of cancer called RAS/BRAF wild-type and certain genetic characteristics assessed by local centers.
The disease must be considered unresectable, meaning it cannot be removed by surgery, as judged by a local medical team.
Be a candidate for treatment with FOLFIRI plus panitumumab, which is a standard treatment for this type of cancer.
Have not received any previous treatments like chemotherapy, radiation, or surgery for metastatic colorectal cancer. Surgery for the primary tumor is allowed before starting treatment.
Be at least 18 years old.
Have an ECOG Performance Status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
Have a disease that can be measured using imaging techniques, according to specific criteria called RECIST 1.1.

Who cannot join the trial?

10 criteria

Patients with a type of cancer that is not **unresectable left-sided RAS/B-RAF wild-type metastatic colorectal cancer** cannot participate. This means the cancer must be on the left side of the colon, cannot be removed by surgery, and must have specific genetic characteristics.
Patients who have already received treatment for their metastatic colorectal cancer are not eligible.
Patients with other serious health conditions that could interfere with the study treatment are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend regular check-ups are not eligible.
Patients with a history of severe allergic reactions to the study drugs or similar drugs are excluded.
Patients who are participating in another clinical trial at the same time are not allowed to join this study.
Patients with certain infections or diseases that could affect the study results are not eligible.
Patients who have had another type of cancer in the past, unless it was successfully treated and has not returned, are excluded.
Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Panitumumab
is a medication used in this 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 help slow down or stop the growth of the cancer.
FOLFIRI
is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three different medications that work together to kill cancer cells or stop them from growing. This combination is often used when the cancer cannot be removed by surgery.

Panitumumab

What is already known about the treatment

Panitumumab – Panitumumab is administered intravenously and is used in combination with chemotherapy for the treatment of certain types of colorectal cancer. It is currently being studied in clinical trials for its effectiveness in treating unresectable left-sided RAS/B-RAF wild-type metastatic colorectal cancer. The main therapeutic indication is for patients with this specific type of colorectal cancer. At the molecular level, Panitumumab works by binding to the epidermal growth factor receptor (EGFR) on cancer cells, blocking the signals that promote cancer cell growth and survival. It is classified as a monoclonal antibody, specifically targeting EGFR to inhibit tumor growth.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. It often 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 travel through the blood 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 specific subtype mentioned, left-sided RAS/B-RAF wild-type, refers to genetic characteristics of the cancer that can influence its behavior and response to treatment.