Recruiting

Study on Optimizing NALIRIFOX and 5-FU for Metastatic Pancreatic Cancer in First-Line Treatment and Exploring Ciprofloxacin in Second-Line Therapy

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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 ductal adenocarcinoma, a type of advanced pancreatic cancer. The study involves several medications, including Oxaliplatin, Levoleucovorin, Gemcitabine, Ciprofloxacin, Fluorouracil, Irinotecan, and Paclitaxel. These medications are used in different combinations to explore their effectiveness in treating this cancer. The purpose of the study is to evaluate how well these treatments work in improving patient outcomes.

The study is divided into two main steps. In the first step, patients receive a combination of NALIRIFOX and 5-FU (a form of Fluorouracil) to see if this approach can help control the cancer for at least six months. In the second step, the study looks at whether adding the antibiotic Ciprofloxacin to a Gemcitabine-based treatment can help patients live longer. The study is designed to be non-comparative and randomized, meaning that participants are randomly assigned to different treatment groups to ensure unbiased results.

Participants in the study will receive their treatments through infusions, which are administered directly into the bloodstream. The study will monitor the patients' health and response to the treatments over a period of time, with regular check-ups and assessments. The goal is to find the most effective treatment strategy for patients with this type of pancreatic cancer, potentially improving their quality of life and survival rates.

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 phase
Upon joining the study, you will begin the first phase of treatment. This involves receiving a combination of medications known as NALIRIFOX. This includes oxaliplatin, irinotecan, levoleucovorin, and fluorouracil. These medications are administered through an infusion, which means they are given directly into your bloodstream through a vein.
The treatment is designed to be given in cycles. Each cycle lasts for a specific period, followed by a rest period to allow your body to recover. The exact schedule and duration of each cycle will be explained to you by the medical team.
Step 2
Maintenance therapy
After completing the initial treatment phase, you will move to a maintenance therapy phase. This involves continuing with fluorouracil and levoleucovorin to help maintain the effects of the initial treatment. These medications are also given by infusion.
The goal of this phase is to keep the cancer under control and to prevent it from growing. The frequency and duration of this maintenance therapy will be determined by your response to the initial treatment.
Step 3
Second-line treatment
If the cancer progresses despite the initial and maintenance treatments, you may enter the second-line treatment phase. This phase involves a different combination of medications, including gemcitabine and possibly ciprofloxacin. Gemcitabine is given by infusion, while ciprofloxacin is taken orally as a tablet.
The purpose of this phase is to explore the effectiveness of adding antibiotics to the chemotherapy regimen. The medical team will monitor your progress closely to assess the treatment's impact.
Step 4
Follow-up and monitoring
Throughout the trial, regular follow-up visits will be scheduled. These visits are important for monitoring your health, assessing the effectiveness of the treatment, and managing any side effects.
During these visits, various tests and examinations will be conducted, such as blood tests and imaging scans, to evaluate your response to the treatment. The medical team will provide guidance and support throughout this process.

Who can join the trial?

15 criteria

Must have metastatic pancreatic ductal adenocarcinoma.
Must provide written informed consent before any study-related procedures.
Must be registered in a National Health Care System.
For Step 1: No previous treatment for metastatic disease and no treatment with any investigational drug within the last 28 days.
For Step 1: No dihydropyrimidine dehydrogenase (DPD) deficiency. This means a specific enzyme in the body must be at a normal level.
For Step 2: Must have metastatic disease.
For Step 2: Must have received L2 therapy after the disease progressed under 5-FU-based chemotherapy.
Must be 18 years or older. If over 75, a specific health score (G8 score) must be 14 or higher.
Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, which indicates the level of daily functioning.
Must have a confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC) through tissue examination.
Must have at least one measurable tumor according to specific medical guidelines (RECIST v 1.1).
Must provide tissue samples for research purposes.
Must have adequate organ function, which includes specific levels of liver enzymes, bilirubin, albumin, hemoglobin, neutrophils, platelets, and kidney function.
For women, must show evidence of being post-menopausal or have a negative pregnancy test before starting the study. Women of childbearing potential and men must use effective contraception during and after the study for specified periods.
Must be willing and able to follow the study protocol, including attending treatment sessions and follow-up visits.

Who cannot join the trial?

10 criteria

Patients who do not have metastatic pancreatic ductal adenocarcinoma cannot participate. This means the cancer must have spread from the pancreas to other parts of the body.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This refers to groups of people who may be at a higher risk of harm or exploitation.
Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent major surgery or are recovering from surgery cannot participate.
Patients who have a known allergy to any of the study medications cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of certain heart conditions cannot participate.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Besancon University Hospital Center
Besançon, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

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Investigated drugs

NALIRIFOX
is a combination therapy used in the treatment of pancreatic cancer. It includes a mix of drugs that work together to stop the growth of cancer cells. This therapy is often used as a first-line treatment, meaning it is one of the first options given to patients with this type of cancer. The goal of using NALIRIFOX is to help control the disease and improve the patient's quality of life.
5-FU
, also known as fluorouracil, is a type of chemotherapy drug used to treat various cancers, including pancreatic cancer. It works by interfering with the cancer cells' ability to grow and divide. In this trial, 5-FU is used as a maintenance therapy, which means it is given to help keep the cancer from coming back after the initial treatment has been successful.
Leucovorin
, also known as folinic acid, is often used alongside 5-FU to enhance its effectiveness. It helps the chemotherapy work better by making cancer cells more sensitive to the treatment. Leucovorin itself is not a chemotherapy drug, but it supports the action of 5-FU in fighting cancer.
Ciprofloxacin
is an antibiotic that is being tested in this trial to see if it can improve the effectiveness of chemotherapy in treating pancreatic cancer. Antibiotics like ciprofloxacin are usually used to treat infections, but in this study, researchers are exploring whether it can also help in controlling cancer by affecting the bacteria in the body, which might play a role in cancer progression.
Gemcitabine
is another chemotherapy drug used to treat pancreatic cancer. It works by slowing or stopping the growth of cancer cells. In this trial, gemcitabine is part of a treatment plan to see if it can help improve survival rates for patients when used in combination with other therapies.

What is already known about the treatment

NALIRIFOX
NALIRIFOX is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness in treating patients with metastatic pancreatic ductal adenocarcinoma, a type of advanced pancreatic cancer. The main purpose of this medication is to help improve the survival rate of patients by maintaining the effects of initial treatment. At the molecular level, NALIRIFOX works by interfering with the DNA of cancer cells, preventing them from growing and dividing. It is classified as a chemotherapy regimen, which is a type of cancer treatment that uses drugs to kill cancer cells.
Ciprofloxacin
Ciprofloxacin is taken orally in the form of a tablet or liquid, or it can be given intravenously. It is an antibiotic that is being explored in clinical trials for its potential role in enhancing the effectiveness of gemcitabine-based chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. The main therapeutic indication is to help improve patient survival when used alongside chemotherapy. Ciprofloxacin works by inhibiting bacterial DNA replication, which can help manage infections that may occur during cancer treatment. It is classified as a fluoroquinolone antibiotic, which is a type of medication used to treat bacterial infections.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that originates in the ducts of the pancreas and has spread to other parts of the body. It begins in the cells lining the pancreatic ducts, which are responsible for transporting digestive enzymes. As the disease progresses, cancer cells invade nearby tissues and organs, leading to the formation of secondary tumors, known as metastases. The spread of cancer can affect various organs, including the liver, lungs, and peritoneum. Symptoms may include abdominal pain, weight loss, jaundice, and changes in stool. The progression of the disease can lead to significant impacts on digestive and metabolic functions.