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Study on Valproic Acid with Bevacizumab and Oxaliplatin/Fluoropyrimidine for Patients with RAS-Mutated Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as 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 specifically looking at cases where there is a mutation in a gene called RAS. The trial is testing a combination of treatments to see if they can help patients live longer without the cancer getting worse. The treatments being studied include valproic acid, which is usually used to treat seizures, and a combination of cancer-fighting drugs: bevacizumab, oxaliplatin, and a group of drugs known as fluoropyrimidines.

The purpose of the study is to find out if adding valproic acid to the standard treatment of bevacizumab and oxaliplatin/fluoropyrimidine regimens can improve the time patients live without their cancer progressing. This is compared to using bevacizumab and oxaliplatin/fluoropyrimidine regimens alone. The study will involve patients receiving these treatments over a period of time, with some patients receiving a placebo instead of valproic acid. The treatments are given either as an infusion, which means they are delivered directly into the bloodstream through a vein, or as tablets taken by mouth.

Participants in the study will be monitored regularly to assess how well the treatment is working and to check for any side effects. The study aims to provide valuable information that could lead to better treatment options for patients with metastatic colorectal cancer with RAS mutations. The trial is expected to continue until 2026, with the hope of finding a more effective treatment strategy for this challenging condition.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.

2 screening and eligibility confirmation

The study team will conduct tests to confirm your eligibility. This includes verifying your diagnosis of colorectal cancer with RAS mutations and ensuring you meet other criteria such as age and health status.

3 treatment phase

You will begin the treatment phase, which involves receiving a combination of medications. These include bevacizumab and oxaliplatin administered through an intravenous infusion, and valproic acid taken orally as a prolonged-release tablet.

Additionally, you will receive fluorouracil through an intravenous infusion or capecitabine as an oral film-coated tablet. The specific dosage and frequency will be determined by the study team based on your individual needs.

4 regular monitoring

Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to assess the progression of your cancer.

5 end of treatment evaluation

At the end of the treatment phase, you will undergo a final evaluation to determine the outcome of the treatment. This will involve similar tests and assessments as during the regular monitoring phase.

6 follow-up period

After completing the treatment, you will enter a follow-up period where the study team will continue to monitor your health and any long-term effects of the treatment. This may involve periodic visits and communication with the study team.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
  • Must be at Stage IV of the disease, meaning the cancer has spread to other parts of the body.
  • Must have RAS mutations, which are specific changes in the cancer cells.
  • Must have evidence of the disease that can be measured, either through clinical examination or imaging tests.
  • Must have an ECOG performance status of 0 to 1, which means the patient is fully active or has some symptoms but can carry out light work.
  • Must have a life expectancy of more than 3 months.
  • Must agree to use an acceptable method of contraception if they are a man or a woman who can have children.
  • Must have adequately recovered from any previous surgery, with at least 28 days since the surgery or biopsy before joining the study.
  • Must provide written informed consent, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

  • Patients who do not have a RAS mutation in their metastatic colorectal cancer. A mutation is a change in the DNA sequence of a gene.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population. This term refers to groups of people who may be at a higher risk of harm or exploitation in a clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
ASL Napoli 2 Nord – Ospedale Santa Maria delle Grazie Pozzuoli Italy
Auhyjyx Odswtuzmfua Ropwzellf Sel Cixqc Potenza Italy
Cmcg Du Cgsd Mwqseafdorca Szbrqt Palermo Italy
Axxkdtj Opvlqatojgg Uldartrpnpnzy Ofzaougv Rjkwbzn Foggia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
24.05.2019

Trial locations

Investigated drugs:

Valproic acid is a medication that is often used to treat seizures and mood disorders. In this clinical trial, it is being tested to see if it can help improve the effectiveness of cancer treatment when used together with other cancer-fighting drugs. The goal is to see if it can help slow down the progression of colorectal cancer that has spread to other parts of the body.

Bevacizumab is a medication that works by blocking a protein called VEGF, which helps tumors grow new blood vessels. By stopping this process, bevacizumab can help slow or stop the growth of cancer. In this trial, it is used in combination with other drugs to see if it can help improve treatment outcomes for patients with metastatic colorectal cancer.

Oxaliplatin is a type of chemotherapy drug that is used to treat colorectal cancer. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this study, oxaliplatin is combined with other medications to see if it can help improve the treatment of colorectal cancer that has spread.

Fluoropyrimidine refers to a group of chemotherapy drugs that are used to treat various types of cancer, including colorectal cancer. These drugs work by interfering with the DNA and RNA of cancer cells, which can prevent them from growing and multiplying. In this trial, fluoropyrimidine is used alongside other treatments to see if it can help improve the outcomes for patients with metastatic colorectal cancer.

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and spreads to other parts of the body, such as the liver or lungs. It begins 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 disease often progresses in stages, starting from localized growths to regional spread, and eventually to distant metastasis. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression.

Trial ID:
2024-516844-25-01
Trial Phase:
Therapeutic exploratory (Phase II)

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