Study of Arfolitixorin, 5-Fluorouracil, Oxaliplatin, and Bevacizumab for Patients with Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. The study is testing a new treatment combination that includes a medication called Arfolitixorin, along with other drugs: 5-fluorouracil, oxaliplatin, and bevacizumab. Arfolitixorin is a form of folate, a vitamin that helps cells grow and divide, and it is being tested to see if it can improve the effectiveness of the other cancer treatments.

The purpose of this study is to evaluate the safety and effectiveness of this combination treatment in patients who have not received any prior treatment for their metastatic colorectal cancer. The study is divided into two phases. In the first phase, the focus is on determining the safest dose of Arfolitixorin that can be given with the other drugs. In the second phase, the study will look at how well the treatment works in shrinking tumors and controlling the cancer.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor participants for any side effects and measure how the cancer responds to the treatment over time. The goal is to find out if this new combination can be a safe and effective option for treating metastatic colorectal cancer.

1 initial treatment phase

The study begins with the administration of arfolitixorin in combination with other medications. These include 5-fluorouracil, oxaliplatin, and bevacizumab. The treatment is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this phase is to evaluate the safety and tolerability of the treatment combination. This involves monitoring for any side effects or reactions to the medications.

2 dose evaluation phase

During this phase, two different doses of arfolitixorin are tested. One is the maximum tolerated dose, and the other is a lower dose. The goal is to determine which dose is more effective and better tolerated.

The effectiveness of the treatment is assessed by measuring the response of the cancer to the medication. This is done using imaging techniques to see if the cancer has shrunk or stopped growing.

3 monitoring and follow-up

Throughout the study, regular monitoring is conducted to track the progress of the treatment. This includes blood tests and other laboratory evaluations to check for any changes in health status.

The study also measures the time until the disease progresses or until any adverse effects occur. This helps in understanding the long-term impact of the treatment.

4 end of treatment evaluation

At the end of the treatment period, a final evaluation is conducted. This includes assessing the overall response to the treatment and any side effects experienced.

The results from this evaluation help in determining the overall success of the treatment and its potential for future use in similar cases.

Who Can Join the Study?

Sign an Informed Consent Form (ICF) and be able to follow the study requirements.
Have a life expectancy of more than 12 weeks.
Female patients must be surgically sterile, postmenopausal for at least 1 year, or have a negative pregnancy test result before starting the study treatment.
Female patients who can have children must agree to use effective birth control methods.
Male patients with female partners who can have children must agree to use effective birth control methods.
Have a confirmed diagnosis of a specific type of colorectal cancer that has spread to other parts of the body and is suitable for a particular treatment regimen.
Provide a sample of the tumor tissue for testing.
Have a healthy heart, with specific requirements for heart rate, blood pressure, and other heart function tests.
Have acceptable blood test results, including hemoglobin, white blood cells, and platelets.
Have proper organ function, with specific limits for liver and kidney tests.
Be at least 18 years old at the time of signing the consent form.
Have a disease that can be measured using imaging tests within 28 days before starting the treatment.
Have a good general health status, as measured by the Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates the ability to carry out daily activities.

Who Cannot Join the Study?

Patients who do not have metastatic colorectal cancer cannot participate. This is a type of cancer that has spread from the colon or rectum to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are not able to tolerate the study medications cannot participate. This means if the medications cause severe side effects, the patient may not be eligible.
Patients who are not able to follow the study procedures cannot participate. This means if a patient cannot attend appointments or follow instructions, they may not be eligible.
Patients who are part of a vulnerable population may not be eligible. This includes groups who may need special protection in research studies.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Muenchen Klinik gGmbH	Munich	Germany
Uflmrjwfcztenbdwjroim Ecpat Aiy	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.04.2025

Trial locations

Investigated drugs:

Arfolitixorin is a medication being studied for its potential to enhance the effectiveness of chemotherapy in treating metastatic colorectal cancer. It is used in combination with other cancer-fighting drugs to see if it can improve treatment outcomes.

5-Fluorouracil is a chemotherapy drug that works by interfering with the growth and spread of cancer cells. It is commonly used to treat various types of cancer, including colorectal cancer.

Oxaliplatin is another chemotherapy medication that is used to treat colorectal cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing.

Bevacizumab is a type of medication known as a monoclonal antibody. It works by blocking a protein that helps cancer cells grow new blood vessels, which are needed for tumors to grow and spread. This can help slow down or stop the growth of cancer.

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. It typically starts 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 progression of the disease can vary, with some patients experiencing rapid spread, while others may have a slower progression. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The disease is often diagnosed at an advanced stage due to the subtlety of early symptoms.

Trial ID:

2024-516802-43-00

Protocol code:

ISO-CC-010

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Arfolitixorin, 5-Fluorouracil, Oxaliplatin, and Bevacizumab for Patients with Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?