Study Comparing Gemcitabine and Paclitaxel Albumin-Bound for Fragile Patients with Non-Resectable Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying treatments for pancreatic cancer, a type of cancer that begins in the tissues of the pancreas. The study is comparing two different treatments for patients whose cancer cannot be removed by surgery. The first treatment involves the use of Gemcitabine, a medication that is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The second treatment is a combination of Gemcitabine and Abraxane (also known as paclitaxel albumin-bound), which is also given through an intravenous infusion but at a reduced dose.

The purpose of this study is to determine which treatment is more effective for patients who are not able to undergo full-dose combination chemotherapy. Participants in the study will be randomly assigned to receive either the standard dose of Gemcitabine or the reduced-dose combination of Gemcitabine and Abraxane. The study will monitor the participants over a period of time to see how the treatments affect their cancer and overall health. The main focus will be on how long the patients live without their cancer getting worse, known as progression-free survival. Other aspects such as overall survival, response to treatment, number of hospitalizations, and quality of life will also be assessed.

This study is designed for patients who are considered fragile or not suitable for full-dose chemotherapy. It aims to provide insights into the best treatment options for these patients, helping to improve their quality of life and manage their condition more effectively. The study will continue until December 2026, with the goal of gathering comprehensive data on the effectiveness and safety of these treatment options.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide oral and written consent to participate.

Eligibility criteria include being 18 years or older, having a confirmed diagnosis of non-resectable pancreatic cancer, and meeting specific health requirements.

2 treatment assignment

The patient will be randomly assigned to one of two treatment groups: standard dose gemcitabine or reduced-dose combination chemotherapy with gemcitabine and paclitaxel albumin-bound (also known as Abraxane).

3 treatment administration

The medications will be administered intravenously, meaning they will be given through a vein.

The standard dose group will receive gemcitabine as a solution for infusion.

The reduced-dose combination group will receive both gemcitabine and paclitaxel albumin-bound as a dispersion for infusion.

4 monitoring and assessments

Throughout the trial, the patient’s health and response to treatment will be closely monitored.

Assessments will include measuring progression-free survival, overall survival, response rate, and quality of life.

Quality of life will be evaluated using a questionnaire at the start and after 8, 16, and 24 weeks.

5 completion of the trial

The trial is expected to continue until December 2026.

Upon completion, the patient’s overall health and treatment outcomes will be reviewed.

Who Can Join the Study?

Must be at least 18 years old.
Any side effects from previous chemotherapy, like nerve damage, should be mild or gone.
Must agree to participate by signing a consent form, both orally and in writing, as required by local rules.
If able to have children, must use effective birth control methods.
Must have a type of pancreatic cancer called adenocarcinoma, confirmed by tests.
Cancer must be non-resectable, meaning it cannot be removed by surgery. This includes cancer that has spread locally or to other parts of the body.
Not suitable for full-dose combination chemotherapy.
Eligible for full-dose gemcitabine or a reduced dose of combination chemotherapy.
Must have a performance status of 2 or less, which means being able to do daily activities with some help.
Must have cancer that can be measured or not measured by tests.
Must have enough healthy blood cells, with specific counts for white blood cells and platelets, checked within two weeks before joining the study.
Must have organs working well enough, with specific levels for bilirubin (a liver function test) and kidney function, checked within two weeks before joining the study.

Who Cannot Join the Study?

Patients who have had a different type of cancer in the past, except for certain skin cancers or cervical cancer that has been treated.
Patients who have serious heart problems, such as heart failure or a recent heart attack.
Patients with severe liver disease, which means the liver is not working well.
Patients with severe kidney disease, which means the kidneys are not working well.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that needs treatment.
Patients who have a known allergy to the study drugs.
Patients who are participating in another clinical trial at the same time.
Patients who have a condition that the study doctors think would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Region Sjaelland	Holbæk	Denmark
Hadurx Hersomni	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Gemcitabine is a medication used in this study to treat patients with non-resectable pancreatic cancer. It is a type of chemotherapy that works by slowing or stopping the growth of cancer cells. In this trial, it is being used to see if it is effective for patients who cannot undergo surgery or are not suitable for full-dose combination chemotherapy.

GemNab is a combination therapy used in this study, which includes gemcitabine and another drug. This combination is given at a reduced dose to see if it is a better treatment option for patients with non-resectable pancreatic cancer who are considered fragile or not fit for the standard full-dose chemotherapy. The goal is to determine if this reduced-dose combination is more effective or better tolerated by these patients.

Pancreatic cancer – This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As the disease advances, it may cause abdominal pain, weight loss, jaundice, and digestive problems. The cancer can spread to nearby organs and lymph nodes, complicating its progression. It is known for its aggressive nature and tendency to metastasize early. The progression of pancreatic cancer can vary, but it typically involves the growth of malignant cells that disrupt normal pancreatic function.

Trial ID:

2024-514291-41-00

Protocol code:

2024-514291-41-00

NCT ID:

NCT05841420

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Gemcitabine and Paclitaxel Albumin-Bound for Fragile Patients with Non-Resectable Pancreatic Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?