Study on the Effectiveness of FOLFOX and Panitumumab for Patients with Metastatic Colorectal Cancer Without RAS Mutation

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What is this study about?

This clinical trial is focused on studying a type of cancer called metastatic colorectal adenocarcinoma, which is a form of colon cancer that has spread to other parts of the body. The study is specifically for patients whose cancer does not have a RAS mutation, a specific change in the cancer cells that can affect how the cancer grows. The purpose of the study is to evaluate how long the disease can be controlled with the treatment being tested.

The treatment being studied includes a combination of medications: FOLFOX, which is a chemotherapy regimen that includes the drugs oxaliplatin, folinic acid, and fluorouracil, and a drug called panitumumab. Panitumumab is a type of medication known as a monoclonal antibody, which is designed to target specific proteins on cancer cells. The study will use a “stop-and-go” strategy, meaning that the treatment will be paused and restarted based on the patient’s response to the therapy. If the cancer progresses while on a maintenance treatment with a drug called fluoropyrimidine, the original treatment will be reintroduced.

Participants in the study will receive the treatment over a period of time, with regular monitoring to assess how well the cancer is being controlled. The study aims to understand the duration of disease control and will also look at other outcomes such as the time until the cancer progresses, the overall survival of patients, and the quality of life during treatment. Some participants may receive a placebo as part of the study design. The trial is expected to continue until the end of 2025.

1 initial treatment phase

The treatment begins with a combination of medications designed to manage metastatic colorectal adenocarcinoma. The medications include capecitabine, folinic acid, oxaliplatin, panitumumab, and fluorouracil.

Capecitabine is administered orally in the form of Xeloda 150 mg film-coated tablets.

Folinic acid is given as a solution for injection or infusion, with a concentration of 10 mg/ml.

Oxaliplatin is provided as a solution for infusion, with a concentration of 5 mg/ml.

Panitumumab is administered as a concentrate for solution for infusion, with a concentration of 20 mg/ml.

Fluorouracil is given as a solution for injection, with a concentration of 1000 mg/20 ml.

2 maintenance treatment phase

After the initial treatment phase, a maintenance treatment is implemented using fluoropyrimidine. This phase follows a ‘stop-and-go’ strategy, which involves pausing and restarting treatment based on the progression of the disease.

The goal of this phase is to maintain disease control and manage symptoms effectively.

3 reintroduction phase

If the disease progresses during the maintenance phase, the initial combination of medications may be reintroduced.

This phase aims to regain control over the disease and extend the duration of disease management.

4 evaluation and monitoring

Throughout the trial, regular evaluations are conducted to monitor the effectiveness of the treatment and the patient’s response.

These evaluations include assessing the duration of disease control, progression-free survival, tumor response, and overall survival.

Quality of life is also monitored using specific questionnaires designed to assess the impact of the treatment on daily living.

Who Can Join the Study?

The patient must have a type of cancer called colorectal adenocarcinoma that has spread to other parts of the body, but it should not have a specific genetic change known as RAS mutation.
The patient should have a prothrombin time (PT) greater than 60%, which is a measure of how well the blood clots, and an albumin level of at least 25 grams per liter, which is a protein in the blood.
The patient should have a life expectancy of at least 3 months.
The patient must be part of a social security scheme.
The patient must be informed about the study and have signed a consent form agreeing to participate.
The cancer must be confirmed as metastatic and cannot be removed by surgery, classified as Stage IV.
The patient should not have had any chemotherapy before, except for specific types given around surgery or as additional treatment, and these should have been stopped for more than 12 months.
There must be at least one tumor that can be measured according to specific guidelines called RECIST v1.1 criteria.
The patient must be 18 years or older.
The patient’s overall health should be rated as 2 or less on a scale used by the World Health Organization (WHO), where lower numbers indicate better health.
The patient should have a certain level of blood cells: neutrophils greater than 1,500 per cubic millimeter, platelets greater than 100,000 per cubic millimeter, and hemoglobin (Hb) greater than 9 grams per deciliter.
The patient should have a creatinine clearance greater than 50 milliliters per minute, which is a measure of kidney function, and 24-hour proteinuria less than 1 gram, which measures protein in the urine.
The patient should have a serum bilirubin level less than 25 micromoles per liter, and levels of liver enzymes such as AST, ALT, and Alk Phos should be less than 2.5 times the upper limit of normal, or less than 5 times if there are liver metastases.

Who Cannot Join the Study?

Patients with other types of cancer besides metastatic colorectal adenocarcinoma cannot participate. This means the cancer 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 in the study details.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
Patients who do not meet the specific health requirements set by the study cannot participate. These requirements are usually related to the patient’s overall health and medical history.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Grand Hopital De Charleroi	Charleroi	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	26.04.2018
France	Not recruiting	26.04.2018

Trial locations

Investigated drugs:

FOLFOX is a combination chemotherapy regimen used to treat colorectal cancer. It includes three main drugs: folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin. This combination works by interfering with the growth of cancer cells, slowing or stopping their spread.

Panitumumab is a targeted therapy used in the treatment of colorectal cancer. It is a monoclonal antibody that specifically targets and binds to the epidermal growth factor receptor (EGFR) on cancer cells. By blocking this receptor, panitumumab helps to prevent the cancer cells from growing and dividing.

Investigated diseases:

Colorectal adenocarcinoma

Metastatic Colorectal Adenocarcinoma – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body. It begins in the glandular cells lining the colon or rectum, which are responsible for producing mucus and other fluids. As the disease progresses, cancer cells can invade nearby tissues and organs, and eventually enter the bloodstream or lymphatic system, spreading to distant sites such as the liver or lungs. 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, abdominal pain, and weight loss, but these can vary depending on the location and extent of the spread. The disease is often diagnosed at an advanced stage due to its ability to spread before causing noticeable symptoms.

Trial ID:

2024-518740-20-00

Protocol code:

FFCD 1605 OPTIPRIME

NCT ID:

NCT03584711

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of FOLFOX and Panitumumab for Patients with Metastatic Colorectal Cancer Without RAS Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?