Recruiting

Study Comparing Gemcitabine and Paclitaxel with Drug Combination for Patients with Advanced Pancreatic Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 advanced pancreatic cancer. The study will compare two different treatment approaches for patients with this condition. One group of patients will receive a combination of gemcitabine and nab-paclitaxel, while the other group will continue with a modified version of a treatment called FOLFIRINOX. FOLFIRINOX is a combination of several drugs, including fluorouracil, irinotecan, oxaliplatin, and calcium folinate. These medications are given to help manage the cancer and improve patient outcomes.

The purpose of this study is to evaluate which treatment approach is more effective in terms of overall survival, which means the length of time patients live after starting the treatment. Patients will be randomly assigned to one of the two treatment groups. The study will involve regular visits to the clinic for treatment administration and monitoring. Treatments will be given through an infusion, which is a method of delivering medication directly into the bloodstream over a period of time. The study will also monitor the quality of life and any side effects experienced by the patients.

Participants in the study will be closely monitored by healthcare professionals throughout the treatment period. The study aims to provide valuable information on the best treatment strategy for patients with advanced pancreatic cancer, potentially leading to improved care and outcomes for future patients. The trial is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Induction phase
The initial phase involves receiving a combination of medications known as modified FOLFIRINOX. This includes fluorouracil, irinotecan hydrochloride, oxaliplatin, and calcium folinate. These medications are administered through an infusion, which is a method of delivering drugs directly into the bloodstream over a set period.
This phase lasts for approximately three months. The goal is to assess the initial response to the treatment.
Step 2
Evaluation
After the induction phase, an evaluation is conducted to determine the effectiveness of the treatment. This involves imaging tests such as CT scans or MRIs to assess the size and spread of the cancer.
The results of this evaluation will guide the next steps in the treatment process.
Step 3
Maintenance or continuation phase
Based on the evaluation results, there are two possible paths: switch maintenance or continuation of the initial treatment.
If the switch maintenance path is chosen, the treatment will involve gemcitabine and nab-paclitaxel, administered through infusion. This phase aims to maintain the response achieved during the induction phase.
If the continuation path is chosen, the modified FOLFIRINOX regimen will continue. The decision between these paths is based on the overall response and health status.
Step 4
Ongoing assessments
Throughout the trial, regular assessments are conducted to monitor the effectiveness of the treatment and any side effects. These assessments include physical exams, blood tests, and imaging studies.
The frequency of these assessments is determined by the study protocol and the patient's condition.
Step 5
End of trial
The trial is expected to conclude by December 16, 2028. At the end of the trial, a final evaluation will be conducted to assess the overall outcomes of the treatment.
The results will contribute to understanding the effectiveness of the treatment options for advanced pancreatic cancer.

Who can join the trial?

16 criteria

The patient must be able and willing to provide written consent and follow the study rules.
The patient must have adequate kidney function, meaning their blood test for creatinine should be within a certain range.
The patient must have adequate blood clotting function, as shown by specific blood tests (INR and PTT) unless they are on blood-thinning medication.
The patient must not have a complete deficiency of a specific enzyme called dihydropyrimidine dehydrogenase (DPYD), which is checked through a genetic test.
Women who can have children must agree to avoid pregnancy by using effective birth control methods during the study and for 7 months after the last treatment.
Women who can have children must have a negative pregnancy test before starting the study.
Men must agree to avoid fathering a child by using effective birth control methods during the study and for 7 months after the last treatment.
Participants must agree not to donate eggs or sperm during the study and for 7 months after the last treatment, as the treatment may affect fertility.
The patient must be at least 18 years old.
The patient must have a confirmed diagnosis of unresectable locally advanced or metastatic pancreatic adenocarcinoma that can be treated in the first-line setting.
The patient must have a disease that can be measured or assessed by a CT scan or MRI, according to specific guidelines.
The patient must provide a sample of their tumor for analysis.
The patient must have an ECOG performance status of 0-1 if they are under 70 years old, or 0 if they are 70 or older. This status measures how well they can perform daily activities.
The patient must have an estimated life expectancy of more than 3 months.
The patient must have adequate blood cell counts, including a certain level of neutrophils, platelets, and hemoglobin. Blood transfusions are allowed if needed.
The patient must have adequate liver function, as shown by specific blood tests for bilirubin and liver enzymes (AST and ALT). If these levels are high, they must be stable for at least 2 weeks and not caused by a blockage in the bile ducts.

Who cannot join the trial?

4 criteria

Patients who do not have advanced pancreatic cancer cannot participate. This means the cancer must be in a later stage and affecting the pancreas, an organ in the abdomen that helps with digestion and blood sugar regulation.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both men and women can participate, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population may be excluded. A vulnerable population includes groups who might have a harder time understanding the study or making decisions about their participation.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Gemcitabine
is a medication used in cancer treatment. It works by slowing or stopping the growth of cancer cells. In this trial, it is used in combination with another drug to see if it can help patients with advanced pancreatic cancer live longer.
Nab-Paclitaxel
is a form of chemotherapy that helps stop the growth of cancer cells by interfering with their division. It is used alongside Gemcitabine in this study to evaluate its effectiveness in treating advanced pancreatic cancer.
Modified FOLFIRINOX
is a combination of chemotherapy drugs used to treat pancreatic cancer. It includes several medications that work together to attack cancer cells in different ways. This trial is comparing the continued use of this combination to a switch to Gemcitabine and Nab-Paclitaxel to see which approach is more effective for patients.

What is already known about the treatment

Gemcitabine
This medication is administered intravenously and is used in the treatment of advanced pancreatic cancer. It is currently well-established in medical literature as a chemotherapy agent. Gemcitabine works by interfering with DNA synthesis, thereby preventing cancer cells from growing and dividing. It belongs to the pharmacological class of antimetabolites.
Nab-Paclitaxel
This drug is also given intravenously and is used alongside Gemcitabine for advanced pancreatic cancer. It is recognized in medical literature as an effective chemotherapy option. Nab-Paclitaxel works by stabilizing microtubules, which inhibits cell division and leads to cancer cell death. It is classified as a taxane, a type of antineoplastic agent.

Investigated diseases

Advanced Pancreatic Cancer – This is a stage of pancreatic cancer where the disease has spread beyond the pancreas to other parts of the body. It often involves the liver, lungs, or the lining of the abdomen. The cancer cells grow uncontrollably, forming tumors that can interfere with the normal function of the pancreas and other organs. Symptoms may include abdominal pain, weight loss, jaundice, and digestive problems. As the disease progresses, it can lead to more severe symptoms and complications. The progression of the disease can vary, but it typically involves the worsening of symptoms and increased tumor growth.