Recruiting

Study of personalized FOLFIRINOX drug combination dosing (fluorouracil, irinotecan, oxaliplatin, and calcium folinate) for patients with pancreatic cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with pancreatic cancer who are receiving a combination chemotherapy treatment called FOLFIRINOX. This treatment consists of four medications: fluorouracil, oxaliplatin, irinotecan, and calcium folinate. These medications are given through an intravenous infusion directly into the bloodstream.

The purpose of this study is to evaluate and improve the dosing of fluorouracil, one of the main components of FOLFIRINOX treatment. The study will measure how the body processes this medication and determine whether personalizing the dose for each patient leads to better results than using standard dosing based on body surface area.

The study is divided into two parts. In the first part, patients will receive standard doses of FOLFIRINOX, and researchers will measure the amount of medication in their blood. In the second part, patients will receive personalized doses of fluorouracil based on their individual needs. Throughout the study, patients will need to provide blood samples to measure medication levels. The total treatment period may last up to 24 months.

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
Initial treatment cycle
You will receive a combination treatment called FOLFIRINOX, which consists of four different medications administered through intravenous infusion:
- Irinotecan (solution for infusion)
- Calcium folinate (solution for injection/infusion)
- Oxaliplatin (concentrate for solution for infusion)
- Fluorouracil (also known as 5-FU, solution for injection/infusion)
Step 2
Blood sampling
During treatment, blood samples will be collected to measure the levels of medications in your body
The main focus is on measuring the level of fluorouracil (5-FU) in your blood over a 46-hour period
Step 3
Dose adjustment period
Your medication doses may be adjusted based on blood test results
The goal is to achieve the right amount of medication in your body within two treatment cycles
The target range for fluorouracil is specifically measured and adjusted to reach optimal levels
Step 4
Ongoing monitoring
Regular assessments will track your response to treatment
Your doctor will monitor for any side effects or complications
Treatment may be delayed by up to 2 days if necessary based on your condition
The study will continue until September 2027

Who can join the trial?

7 criteria

Must have a confirmed diagnosis of pancreatic cancer through pathological testing (for Part B of the study: cancer must be unresectable locally advanced or metastatic)
Must be scheduled to begin FOLFIRINOX treatment (a combination chemotherapy regimen used to treat pancreatic cancer)
Must be 18 years of age or older
Must be willing and able to provide written informed consent to participate in the study
Must be willing and able to undergo additional blood sampling for 5-FU analysis (5-FU is one of the chemotherapy medications used in the treatment)
Must have a WHO performance status of 0-2 (a scale that measures a patient's ability to perform daily activities, where 0 means fully active and 2 means able to do light activities but unable to work)
Can be either male or female

Who cannot join the trial?

12 criteria

Age below 18 years or above 75 years
Previous treatment with FOLFIRINOX chemotherapy regimen
Known allergies or hypersensitivity to any of the study medications
Presence of other types of cancer besides pancreatic cancer
Severe heart problems or unstable heart conditions
Severe liver problems (impaired liver function)
Severe kidney problems (impaired kidney function)
Pregnancy or breastfeeding
Active infections requiring treatment
Participation in other clinical trials within the last 30 days
Mental conditions that could affect the ability to provide informed consent
Inability to follow study procedures or attend scheduled visits

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

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Investigated drugs

FOLFIRINOX
is a combination chemotherapy treatment that consists of several medications working together. It includes three main chemotherapy drugs:
5-Fluorouracil (5-FU)
is a chemotherapy medication that works by stopping cancer cells from making new DNA, which prevents them from growing and dividing. It is given through an intravenous (IV) infusion into your vein.
Irinotecan
is a chemotherapy drug that blocks an enzyme needed for cancer cell division. It works by preventing cancer cells from repairing their DNA, which leads to their death. It is administered through an IV infusion.
Oxaliplatin
is a platinum-based chemotherapy medication that damages the DNA of cancer cells, preventing them from multiplying. It is given through an IV infusion.
Leucovorin
(also known as folinic acid) is not a chemotherapy drug but a supportive medication that helps enhance the effectiveness of 5-FU while reducing its side effects. It is given through an IV infusion.

What is already known about the treatment

FOLFIRINOX
A combination chemotherapy regimen used primarily for treating pancreatic cancer, consisting of four drugs: fluorouracil (5-FU), leucovorin, irinotecan, and oxaliplatin. It is administered intravenously in cycles under careful medical supervision, with each drug playing a specific role in fighting cancer cells. The treatment works by interfering with cancer cell DNA replication and division through multiple mechanisms, making it a potent but complex therapy option. This regimen is classified as a multi-agent cytotoxic chemotherapy protocol and represents one of the most aggressive standard treatment approaches for advanced pancreatic cancer.
5-FU (Fluorouracil)
A cornerstone chemotherapy medication administered intravenously that belongs to the antimetabolite class of drugs. It works by interfering with DNA synthesis in rapidly dividing cells, particularly targeting cancer cells by blocking an enzyme needed for cell growth. 5-FU is widely used in the treatment of various cancers, including pancreatic cancer, and its effectiveness is often optimized through careful dose monitoring and adjustment based on patient response and blood levels.

Investigated diseases

Pancreatic Cancer – A condition that begins when abnormal cells start growing in the pancreas, an organ located behind the stomach. The disease typically develops when cells in the pancreas begin to grow out of control, forming masses called tumors. These abnormal cells can affect both the exocrine part of the pancreas (which produces digestive enzymes) and the endocrine part (which produces hormones like insulin). The cancer can interfere with the pancreas's normal functions of helping to digest food and regulate blood sugar. As the disease progresses, it can spread to nearby organs and blood vessels. The condition often develops gradually, and early stages may not cause noticeable symptoms.