Not recruiting

Study Comparing Irinotecan, Oxaliplatin, and Fluorouracil Combination with Paclitaxel and Gemcitabine for Patients with Metastatic 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 is focused on studying treatments for metastatic pancreatic cancer, a type of cancer that has spread from the pancreas to other parts of the body. The study aims to compare the effectiveness of two different chemotherapy treatments. One treatment involves a combination of irinotecan liposome injection, oxaliplatin, and 5-fluorouracil (also known as 5-FU) with leucovorin. The other treatment combines nab-paclitaxel with gemcitabine. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate which treatment is more effective in improving the overall survival of patients who have not previously received chemotherapy for their metastatic pancreatic cancer. Participants in the study will be randomly assigned to receive one of the two treatment regimens. The study will monitor the participants over a period to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will receive regular medical check-ups and tests to track their health and the progress of their cancer. The study will also look at other outcomes, such as how long the cancer stays under control and the overall response rate to the treatments. This research is important for understanding which treatment option may offer better outcomes for patients with metastatic pancreatic cancer.

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
Randomization
Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will receive one of two different combinations of medications, but neither you nor the study team will choose which one.
Step 2
Treatment administration
If you are in the first group, you will receive a combination of irinotecan liposome injection, oxaliplatin, and 5-fluorouracil (5-FU) with leucovorin (LV). These medications will be given to you through an intravenous (IV) line, which means they will be administered directly into your bloodstream.
If you are in the second group, you will receive nab-paclitaxel and gemcitabine, also through an IV line.
The specific dosage, frequency, and duration of each medication will be explained to you by the study team, and they will monitor your health throughout the treatment.
Step 3
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and possibly imaging tests like CT scans or MRIs to assess how the treatment is affecting your cancer.
You will be asked to report any side effects or changes in your health to the study team immediately.
Step 4
End of treatment
Once the treatment period is over, you will have a final evaluation to determine the overall effect of the treatment on your health and cancer.
The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who can join the trial?

21 criteria

Must sign an Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
Must have an electrocardiogram (ECG) with no significant issues. An ECG is a test that checks your heart's electrical activity.
Must have normal blood clotting tests, specifically prothrombin time and partial thromboplastin time, which measure how well your blood clots.
No significant problems in a urinalysis, which is a test of your urine.
If you have HIV, you can participate if:
- Your CD4 count is 350 or higher, which indicates a healthy immune system.
- Your viral load is undetectable, meaning the virus is not active in your blood.
- You are not taking medications that interfere with the study drugs.
- You are expected to live a long time with HIV if cancer were not present.
- You have been stable on antiretroviral therapy for at least 4 weeks and are willing to continue it.
- Your HIV is not resistant to multiple drugs.
- Must be 18 years or older. Women who can become pregnant must test negative for pregnancy and agree to use effective birth control. Men must agree to use condoms.
- Must have a confirmed diagnosis of adenocarcinoma of the pancreas that has not been treated in its advanced stage.
- The initial diagnosis of advanced disease must have been made within 6 weeks before screening for the study.
- Must have at least one measurable tumor that can be seen on a CT scan or MRI, which are imaging tests that create pictures of the inside of your body.
- Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
- Must have adequate blood health:
  - Absolute neutrophil count of 2000 or more, which indicates a healthy level of white blood cells.
  - Platelet count of 100,000 or more, which helps with blood clotting.
  - Hemoglobin level of 9 g/dL or more, which is a measure of red blood cells.
  - Must have adequate liver function:
    
    Serum total bilirubin level of 1.5 times the upper limit of normal or less, which indicates healthy liver function.
    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of 2.5 times the upper limit of normal or less, which are enzymes that indicate liver health.
    Must have adequate kidney function with a creatinine clearance of more than 30 mL/min, which measures how well your kidneys are working.

Who cannot join the trial?

5 criteria

Patients who have already received chemotherapy for their metastatic pancreatic adenocarcinoma cannot participate. This means if you have had treatment with drugs to kill cancer cells for this condition, you are not eligible.
Patients with other serious health conditions that might interfere with the study treatment or its evaluation are excluded. This means if you have other major health issues, you may not be able to join.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who are unable to follow the study procedures or attend the required visits are not eligible. This means if you cannot commit to the study schedule, you cannot take part.
Patients with known allergies to the study drugs or their components are excluded. If you have had allergic reactions to similar medications, you cannot join the study.

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Verified sites

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Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Verified
Badalona, Spain

Trial locations

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Investigated drugs

Irinotecan Liposome Injection
is a medication used in this trial to treat pancreatic cancer. It is a special form of irinotecan, which is a drug that helps stop cancer cells from growing and dividing. The liposome part means that the drug is enclosed in tiny fat-like particles, which can help it stay in the body longer and target the cancer cells more effectively.
Oxaliplatin
is another medication used in this trial. It is a type of chemotherapy that works by damaging the DNA of cancer cells, which prevents them from growing and multiplying. This helps to slow down or stop the spread of cancer in the body.
5-Fluorouracil (5-FU)
is a chemotherapy drug that is part of the treatment regimen in this trial. It works by interfering with the DNA and RNA of cancer cells, which are essential for their growth and survival. By doing this, it helps to kill the cancer cells or stop them from spreading.
Leucovorin
is used in combination with 5-fluorouracil in this trial. It is not a chemotherapy drug itself, but it helps enhance the effectiveness of 5-fluorouracil. Leucovorin helps the body use 5-fluorouracil more effectively, which can improve the treatment's ability to fight cancer.
Nab-Paclitaxel
is a form of chemotherapy used in this trial. It is a drug that helps stop cancer cells from dividing and growing. The "nab" part means that the drug is bound to a protein called albumin, which can help it get into the cancer cells more easily and reduce some side effects.
Gemcitabine
is another chemotherapy drug used in this trial. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. This helps to slow down or stop the spread of cancer in the body.

What is already known about the treatment

Irinotecan Liposome Injection
This medication is administered through an injection into the bloodstream and is currently being studied in clinical trials for its effectiveness in treating metastatic pancreatic adenocarcinoma, a type of advanced pancreatic cancer. It is part of a treatment regimen that includes other drugs like oxaliplatin and 5-fluorouracil/leucovorin. Irinotecan liposome works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. It belongs to a class of drugs known as topoisomerase inhibitors, which are used to stop the growth of cancer cells.
Oxaliplatin
Oxaliplatin is given as an intravenous infusion and is being tested in combination with other drugs for treating metastatic pancreatic adenocarcinoma. It is a chemotherapy drug that helps to kill cancer cells by damaging their DNA, which stops them from growing and dividing. Oxaliplatin is classified as a platinum-based chemotherapy, which is commonly used to treat various types of cancer.
5-Fluorouracil/Leucovorin
This combination is administered through an intravenous infusion and is part of a treatment plan for metastatic pancreatic adenocarcinoma. 5-Fluorouracil works by disrupting the DNA and RNA of cancer cells, which prevents them from growing and multiplying, while leucovorin enhances the effectiveness of 5-fluorouracil. This combination is classified as an antimetabolite, which is a type of chemotherapy that targets cancer cell growth.
Nab-Paclitaxel
Nab-paclitaxel is delivered via an intravenous infusion and is being evaluated for its role in treating metastatic pancreatic adenocarcinoma. It works by inhibiting the normal function of microtubules, which are structures that help cells divide, thereby stopping cancer cells from growing and spreading. Nab-paclitaxel is part of a group of drugs known as taxanes, which are used to treat various cancers.
Gemcitabine
Gemcitabine is administered through an intravenous infusion and is being studied for its effectiveness in combination with nab-paclitaxel for treating metastatic pancreatic adenocarcinoma. It works by incorporating itself into the DNA of cancer cells, preventing them from replicating and causing them to die. Gemcitabine is classified as an antimetabolite, a type of chemotherapy that targets the growth of cancer cells.

Investigated diseases

Metastatic Pancreatic Adenocarcinoma – This is a type of cancer that begins in the tissues of the pancreas and has spread to other parts of the body. It originates from the glandular cells of the pancreas, which are responsible for producing digestive enzymes. As the disease progresses, cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. The spread of cancer to distant organs is known as metastasis, which can affect the liver, lungs, and peritoneum, among other areas. The progression of the disease often leads to symptoms such as abdominal pain, weight loss, and jaundice. The disease is typically aggressive, with rapid growth and spread.