Recruiting

Study on Regorafenib with Cyclophosphamide, Capecitabine, and Aspirin 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 treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study will explore the use of several medications, including Regorafenib (also known by its code name BAY 73-4506), Capecitabine (marketed as Xeloda), Cyclophosphamide (marketed as Endoxan), and low-dose Aspirin (marketed as Kardegic). Additionally, the study will involve chemotherapy drugs such as Oxaliplatin, Irinotecan, Bevacizumab, and Fluorouracil.

The purpose of the study is to evaluate the effectiveness of using Regorafenib in combination with other treatments as an initial therapy before starting chemotherapy for patients with metastatic colorectal cancer. The study will be conducted in two phases. In the first phase, the focus will be on the best response to the treatment, while the second phase will look at overall survival, which means how long patients live after starting the treatment.

Participants in the study will receive the combination of medications for a period of two months. After this initial treatment, they will proceed to receive chemotherapy. The study aims to determine if this approach can improve the response to treatment and increase the survival time for patients with metastatic colorectal cancer. The trial will also monitor the safety and any side effects of the treatments used.

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
Induction therapy
The initial phase involves taking regorafenib in combination with metronomic cyclophosphamide, capecitabine, and low-dose aspirin for a duration of 2 months.
Regorafenib is administered orally. Cyclophosphamide and capecitabine are also taken orally, while aspirin is taken in a low-dose oral form.
Step 2
Chemotherapy initiation
Following the induction therapy, chemotherapy is initiated as the second line of treatment for metastatic colorectal cancer.
The specific chemotherapy regimen will be determined based on individual patient needs and response to the induction therapy.
Step 3
Treatment evaluation
During the treatment period, the best objective response is evaluated using specific criteria to assess the effectiveness of the therapy.
This evaluation helps in determining the overall survival and progression-free survival of the patient.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring is conducted to assess health-related quality of life and any adverse events.
Patients may be required to complete questionnaires and undergo various assessments to track their response to treatment and any side effects experienced.

Who can join the trial?

14 criteria

Patients must have **metastatic colorectal cancer** that has been confirmed by a lab test and is getting worse after the first round of chemotherapy, with or without additional targeted therapy.
There should be no issues with using **iodine contrast media** during a CT scan. This is a special dye used to improve the clarity of the images.
Women who can have children must have a negative pregnancy test within 14 days before starting the study drug and continue to use birth control during the study and for 210 days after the last dose of the study drug. Men must also use birth control during the study.
Participants must sign and date a form to show they understand and agree to the study.
Participants must be able to follow the study rules, as judged by the study doctor.
Participants must be registered in a national health care system.
Participants must have been treated for their metastatic disease with specific chemotherapy regimens as the first treatment. These include FOLFOX, FOLFIRI, FOLFIRINOX, FOLFOXIRI, and combinations with anti-VEGFA (like bevacizumab) or anti-EGFR.
Participants should have shown resistance to the first line of chemotherapy, meaning the disease got worse during or shortly after the first treatment, or came back within 6 months after stopping treatment or surgery.
Participants should have a life expectancy of at least 3 months.
Participants must be 18 years or older.
Participants should have a **performance status** of 0 or 1 according to the ECOG-WHO scale, which measures how well they can perform daily activities.
Participants must have a measurable disease as defined by specific imaging criteria (RECIST v1.1).
Participants must have a specific **molecular status**: microsatellite-stable (MSS), no BRAF V600E mutation, and a known RAS status.
Participants must have adequate **bone marrow, liver, and kidney functions**. This includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, kidney filtration rate, and protein in urine.

Who cannot join the trial?

5 criteria

Patients with other types of cancer besides **metastatic colorectal cancer** cannot participate. **Metastatic** means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.

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Verified sites

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

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Centr Georges Francois Leclerc
Dijon, France
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Centre Hospitalier Universitaire De Montpellier
Montpellier, France
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Centre Hospitalier Universitaire De Poitiers
Poitiers, France

Trial locations

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Investigated drugs

Regorafenib
is a medication used in this trial as part of an induction therapy. It is designed to help control the growth of cancer cells in patients with metastatic colorectal cancer. It works by blocking certain proteins that promote cancer cell growth.
Cyclophosphamide
is a chemotherapy drug used in this trial in a metronomic (low-dose, continuous) manner. It helps to slow or stop the growth of cancer cells by interfering with their DNA.
Capecitabine
is another chemotherapy medication included in the trial. It is taken orally and works by interfering with the DNA production of cancer cells, which prevents them from growing and dividing.
Aspirin
is used in a low-dose form in this trial. It is commonly known for its pain-relieving and anti-inflammatory effects, but in this context, it is used to potentially enhance the effects of the other cancer treatments.

What is already known about the treatment

Regorafenib – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer. The main therapeutic indication is for use in patients with this type of cancer, particularly in combination with other treatments. Regorafenib works by inhibiting multiple protein kinases, which play a role in tumor growth and progression. It is classified as a multikinase inhibitor in pharmacology.

Investigated diseases

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. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it can lead to more severe symptoms depending on the organs affected. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower course. The focus of treatment often involves managing symptoms and slowing the spread of cancer.