Study of Valproic Acid, Panitumumab, and Irinotecan for Patients with Metastatic Colorectal Cancer with RAS/BRAF Wild-Type

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called . This is a form of colon cancer that has spread to other parts of the body and does not have certain genetic mutations known as RAS or BRAF. The study is investigating the effects of combining a medication called with a treatment regimen that includes and . Panitumumab is a type of medication that targets specific proteins on cancer cells, while irinotecan is a chemotherapy drug. Valproic acid is typically used to treat seizures but is being tested here for its potential to enhance cancer treatment.

The purpose of the study is to evaluate whether adding valproic acid to the standard treatment of panitumumab and irinotecan can improve outcomes for patients. The study is divided into two parts. In the first part, patients will receive either the standard treatment or the standard treatment combined with valproic acid. The second part will focus on patients who have progressed on the standard treatment, assessing the effects of adding valproic acid to their regimen. The study will monitor patients over a period of time to see how well they respond to the treatments and to check for any side effects.

Participants in the study will receive treatments through , which means the medication is delivered directly into the bloodstream, and tablets, which are taken by mouth. The study aims to determine if the combination of these treatments can help control the cancer more effectively than the standard treatment alone. The trial will also look at the overall health and quality of life of the participants during the study period.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process is known as randomization and ensures that each participant has an equal chance of receiving any of the treatment options being tested.

2 treatment phase 1

In the first part of the study, the patient will receive a combination of medications. This includes panitumumab and irinotecan, both administered through infusion. Additionally, valproic acid will be taken orally in the form of prolonged-release tablets. The treatment continues until the disease progresses or side effects become unacceptable.

The goal of this phase is to assess the effectiveness of the treatment combination in controlling the cancer. The patient’s health and response to the treatment will be closely monitored.

3 evaluation at 16 weeks

After 16 weeks, the patient’s condition will be evaluated to determine the progression-free survival rate. This measures the time from the start of treatment until the disease progresses or the patient passes away from any cause.

4 treatment phase 2

If the patient progresses on the standard treatment, they may enter the second part of the study. In this phase, valproic acid is added to the existing treatment of panitumumab and irinotecan. The treatment continues until further progression or unacceptable side effects occur.

The effectiveness of adding valproic acid to the treatment will be assessed, focusing on the patient’s survival and disease control.

5 evaluation at 8 weeks

In the second part of the study, the patient’s condition will be evaluated after 8 weeks to determine the progression-free survival rate. This measures the time from the start of the second phase treatment until the disease progresses or the patient passes away from any cause.

6 ongoing assessments

Throughout the study, the patient’s response to treatment will be regularly assessed using various criteria, including tumor response and overall survival. Safety and quality of life will also be monitored through questionnaires and reports on any side effects experienced.

Who Can Join the Study?

Provide a signed agreement to participate in the study and related research.
Have a disease that can be measured using imaging tests, following specific guidelines called RECIST 1.1.
Have a life expectancy of more than 12 weeks.
Have healthy blood cell levels, including a certain number of white blood cells, platelets, and hemoglobin.
Have a healthy liver, with specific levels of substances like bilirubin and liver enzymes (AST/ALT).
Have healthy kidneys, with specific levels of a substance called creatinine or a certain rate of kidney function.
Have normal levels of certain minerals in the blood, such as magnesium, calcium, sodium, and potassium.
Be 18 years of age or older, regardless of gender.
Have a confirmed diagnosis of a type of cancer called colorectal adenocarcinoma.
Have cancer that has spread to other parts of the body (metastatic disease).
Have a specific genetic status called RAS/BRAF wild-type at the initial diagnosis, confirmed by a local center using a method approved by the European Medicines Agency (EMA), and known status of MMR/MSI.
Have a RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type status confirmed by a blood test at the start of the study.
Have previously responded well to a type of treatment called anti-EGFR drug, with either a complete or partial response, or stable disease for at least 6 months.
Have received at least two different treatments for cancer, with specific conditions regarding previous treatments.
Have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work, according to a scale called the Eastern Cooperative Oncology Group (ECOG) Performance Status.

Who Cannot Join the Study?

Patients with a different type of cancer than the one being studied, which is called RAS/BRAF wild-type metastatic colorectal cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
ASL Napoli 2 Nord – Ospedale Santa Maria delle Grazie	Pozzuoli	Italy
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta	Caserta	Italy
Aoxgmkn Ojgvjwyoeus Rykaliqop Sbz Chofz	Potenza	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Valproic Acid is being studied for its potential to enhance the effectiveness of cancer treatment. In this trial, it is combined with other cancer therapies to see if it can improve outcomes for patients with a specific type of colorectal cancer.

Panitumumab is a medication used to treat certain types of cancer. It works by targeting and blocking a specific protein on the surface of cancer cells, which can help slow down or stop the growth of the cancer.

Irinotecan is a chemotherapy drug used to treat cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is used in combination with other treatments to assess its effectiveness.

Investigated diseases:

Colorectal cancer metastatic

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 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 can cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it may lead to more severe complications depending on the organs affected. The progression of metastatic colorectal cancer can vary greatly among individuals, influenced by factors such as the cancer’s genetic makeup and the patient’s overall health.

Trial ID:

2024-514420-16-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Valproic Acid, Panitumumab, and Irinotecan for Patients with Metastatic Colorectal Cancer with RAS/BRAF Wild-Type

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?