Study of FOLFOX6m, Bevacizumab, and Irinotecan for Patients with Colorectal Cancer and Liver Metastases

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What is this study about?

This clinical trial is focused on studying treatments for colorectal cancer that has spread to the liver, which is known as metastatic disease. The study involves several medications, including Avastin (bevacizumab), Irinotecan Hydrochloride Trihydrate, Folinic Acid (also known as leucovorin), Erbitux (cetuximab), Oxaliplatin, Fluorouracil, and Vectibix (panitumumab). These medications are used in combination with a procedure called hepatic chemoembolization, which is a treatment that delivers chemotherapy directly to the liver.

The purpose of the study is to evaluate how well these treatments work in reducing the size of liver tumors in patients with colorectal cancer. Participants will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of up to 54 weeks, during which the effects of the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effectiveness of the treatments.

Throughout the study, the health of the participants will be closely monitored to assess the response of the cancer to the treatment and to check for any side effects. The study aims to understand the overall survival time, which is the time from starting the study to the time of death from any cause, and progression-free survival, which is the time from starting the study to the time the cancer progresses or the participant passes away. The study will also look at the proportion of patients who can undergo surgery to remove liver metastases completely.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the study criteria.

2 treatment plan discussion

The treatment plan is explained, including the medications involved and their administration method. The patient is informed about the intravenous infusion process, which is the method used for all medications in this study.

3 medication administration

The patient receives a combination of medications through intravenous infusion. These include bevacizumab, irinotecan hydrochloride trihydrate, folinic acid, cetuximab, oxaliplatin, fluorouracil, and panitumumab. The specific dosage and frequency are determined by the study protocol and the patient’s condition.

4 regular monitoring

Throughout the study, the patient’s health is regularly monitored. This includes routine blood tests and imaging studies to assess the response to treatment and check for any side effects.

5 evaluation of response

At six months, the patient’s response to the treatment is evaluated using imaging techniques. The goal is to measure any changes in tumor size according to specific criteria.

6 follow-up visits

The patient attends follow-up visits to monitor overall health and any long-term effects of the treatment. These visits continue until the end of the study period.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must have colorectal cancer with cancer spread only to the liver. This includes:
- More than 3 cancer spots in the liver or spots larger than 5 cm.
- If the cancer spots are fewer than 3 or smaller than 5 cm, they can still participate if the cancer appeared at the same time as the primary tumor or within 12 months after surgery for the primary tumor.
- If the main tumor has not been removed, it must be clinically stable, meaning it is not getting worse.
The disease must be measurable according to specific medical guidelines (RECIST version 1.1).
Patients must have adequate bone marrow function, which means:
- Hemoglobin (a protein in red blood cells) of at least 9.0 g/dL. If lower, patients can receive a blood transfusion before joining the study.
- Platelet count of at least 100 x 10⁹ / L.
- Absolute neutrophil count (ANC) of at least 1.5 x 10⁹ / L.
Patients must have adequate liver function, which includes:
- Serum bilirubin (a substance made by the liver) of no more than 1.5 times the upper limit of normal (ULN).
- ALT and AST (liver enzymes) of no more than 5 times ULN.
- Alkaline phosphatase of no more than 5 times ULN.
Patients must have adequate kidney function, which means:
- Creatinine (a waste product in the blood) of less than 1.5 mg/dL.
- BUN (blood urea nitrogen) of less than 50 mg/dL.
- Blood urea levels of less than 18 mmol/L.
- Albumin (a protein in the blood) of more than 3.0 g/dL.
Patients must have an ECOG Performance Status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Patients must be able to understand the study information and give their written consent to participate.
Women and men who can have children must agree to abstain from sexual activity or use barrier contraceptive methods during the study and must have a negative pregnancy test.

Who Cannot Join the Study?

Patients with other types of cancer besides colorectal cancer.
Patients with cancer spread to areas other than the liver.
Patients with severe liver disease not related to cancer.
Patients who have had major surgery within the last 4 weeks.
Patients who are currently receiving other cancer treatments.
Patients with uncontrolled infections.
Patients with severe heart problems.
Patients with severe kidney problems.
Patients with severe lung problems.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medication.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Ptux Tmnle Hzhhknvu Uyqauwnpwizu	Sabadell	Spain
Hjcjksfx Dl Ll Smvmd Ceey I Srku Pit	Barcelona	Spain
Fociuymgb Phsx Lz Imdetkipknzqz Brmaqjaoq Dzd Hwpnrvjb Ueuemxmzcmbvk Lo Plj	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	29.06.2021

Trial locations

Investigated drugs:

FOLFOX6m is a combination chemotherapy treatment used to fight colorectal cancer. It includes a mix of drugs that work together to stop cancer cells from growing and spreading. This treatment is often used when the cancer has spread to other parts of the body, like the liver.

Monoclonal Antibody (anti-EGFR) is a type of targeted therapy that helps the immune system recognize and attack cancer cells. It specifically targets a protein called EGFR, which is often found on the surface of cancer cells. By blocking this protein, the therapy can slow down or stop the growth of the cancer.

Bevacizumab is another targeted therapy that works by blocking a protein called VEGF. This protein helps cancer cells form new blood vessels, which they need to grow. By stopping this process, bevacizumab can help slow the growth of the cancer.

Lifepearls-Irinotecan is a treatment used in a procedure called hepatic chemoembolization. This involves delivering chemotherapy directly to the liver, where it can target cancer cells more effectively. Irinotecan is a chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from multiplying.

Investigated diseases:

Colorectal cancer metastatic

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby. The cancer may spread to other parts of the body, most commonly the liver, lungs, and lymph nodes. Symptoms can include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.

Trial ID:

2024-517782-16-00

Protocol code:

GEMCAD-1802

NCT ID:

NCT04595266

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of FOLFOX6m, Bevacizumab, and Irinotecan for Patients with Colorectal Cancer and Liver Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?