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

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What is this study about?

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.

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)

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

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

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 Study?

  • 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 Study?

  • 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

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
Isala Klinieken Stichting Zwolle The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Lruyp Uchpsbxsdyus Muyrgmi Cbipbdt (wgnpa Leiden The Netherlands
Agdxqinze Upa Amsterdam The Netherlands
Ejigmnd Uanweklshbls Mxuznic Cfkungm Rtekwccxe (dqjaptd Mxm Rotterdam The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
02.09.2024

Trial locations

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.

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.

Trial ID:
2024-510576-21-00
Protocol code:
PERFUPANC-001
Trial Phase:
Therapeutic exploratory (Phase II)

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