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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Azienda Sanitaria Territoriale Di Pesaro E Urbino Pesaro Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Humanitas Istituto Clinico Catanese S.p.A. Misterbianco Italy
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Azienda USL Toscana Centro Prato Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Hospital Consorziale Policlinico Bari Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
ASST Ospedale Maggiore di Crema Crema Italy
Arbifzs Ottoalcvilv Uukbjiotkppkz Pyfye Parma Italy
Iyncrn Iarnqekh Feuntuwtdhija Onrlpnmbfkb Rome Italy
Imskykfi Rwfeefvkl Pnq Ln Swzike Dra Tzslpe Dxin Akiivas Itcz Srcrfz Meldola Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
16.12.2024

Trial locations

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.

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.

Trial ID:
2024-515214-41-00
Protocol code:
PANThEON
Trial Phase:
Therapeutic confirmatory (Phase III)

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