Study of fluorouracil, irinotecan and oxaliplatin combination therapy for patients with metastatic pancreatic ductal adenocarcinoma who progressed after gemcitabine treatment

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What is this study about?

This clinical trial aims to evaluate treatments for metastatic pancreatic ductal adenocarcinoma, a type of pancreatic cancer that has spread to other parts of the body. The study will test two different treatment combinations after patients have previously received treatment with gemcitabine alone or combined with Abraxane. The treatments being studied include combinations of medications called fluorouracil, oxaliplatin, and irinotecan, along with supportive medications.

Patients will receive treatment through intravenous infusion, which means the medications will be given directly into a vein. The medications will be administered in cycles over several months. During treatment, doctors will monitor how well the cancer responds and check for any side effects. The main goal is to measure how many patients have their cancer remain stable or improve after about 3 months of treatment.

The study will also track other important factors such as survival time, tumor response, and safety of the treatments. Researchers will collect blood and tissue samples to learn more about how the treatments work. The trial is expected to continue until late 2028.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups for metastatic pancreatic cancer after previous treatment with gemcitabine.

Your doctor will verify that you meet all health requirements, including adequate kidney, liver, and blood function.

2a Treatment Group A (5-FU + NALIRI)

If assigned to this group, you will receive:

– Fluorouracil (5-FU) through intravenous infusion

– Naliri (liposomal irinotecan) through intravenous infusion

The medications will be administered according to a specific schedule determined by your healthcare team.

2b Treatment Group B (5-FU + NALIRINOX)

If assigned to this group, you will receive:

– Fluorouracil (5-FU) through intravenous infusion

– Naliri (liposomal irinotecan) through intravenous infusion

– Oxaliplatin through intravenous infusion

The medications will be administered according to a specific schedule determined by your healthcare team.

3 Regular monitoring

Your condition will be monitored through regular medical examinations and tests.

Imaging scans will be performed to assess how the tumor responds to treatment.

Blood samples will be taken to monitor your health status.

The medical team will check for any side effects of the treatment.

4 Day 85 evaluation

A key evaluation will occur at day 85 to determine if the cancer has progressed.

The evaluation will include imaging scans to measure the tumor size.

Your overall health status will be assessed.

5 Continued monitoring

Regular evaluations will continue throughout the study period.

Treatment may continue as long as it provides benefit and is well-tolerated.

The study is planned to continue until December 2028.

Who Can Join the Study?

Must be at least 18 years old
Must have confirmed pancreatic cancer that has spread to other parts of the body, proven by tissue examination
Must have had disease progression after initial treatment with Gemcitabine-Abraxane or Gemcitabine alone
Must have a good performance status (ECOG 0 or 1), meaning able to perform daily activities with minimal assistance
Must have cancer that can be measured by imaging tests (measurable disease)
Must have nerve problems (peripheral neuropathy) less than grade 2 severity
Must have adequate:
- Kidney function (creatinine levels near normal range)
- Liver function (bilirubin levels near normal range)
- Blood cell counts (including white cells, platelets, and hemoglobin)
Must have normal or near-normal blood clotting tests
Must have a life expectancy of at least 12 weeks
Must use effective birth control if able to conceive children
Must sign an informed consent form

Who Cannot Join the Study?

History of any other cancer within 3 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
Known brain metastases (cancer that has spread to the brain) or active central nervous system disease
Major surgery within 4 weeks before starting the study
Severe heart conditions, including:
- Heart attack within the last 6 months
- Unstable angina (chest pain)
- Severe heart failure
Active, uncontrolled infections requiring treatment
Known HIV, active hepatitis B, or active hepatitis C infection
Pregnancy or breastfeeding
Any psychological, social, or medical condition that would interfere with study participation
Previous participation in another clinical trial within 4 weeks before this study
Known allergies or severe reactions to similar medications used in this study
Severe liver or kidney problems that could affect drug processing in the body
Use of medications that could interact with the study treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Az Maria Middelares Gent	Gent	Belgium
AZ Turnhout	Turnhout	Belgium
Grand Hopital De Charleroi	Charleroi	Belgium
Sint-Lucas General Hospital	Brugge	Belgium
CHC MontLegia	Liege	Belgium
CHU Helora	La Louviere	Belgium
Czrhgzxkt Uvsjmwsivkljag Spbkermst	Woluwe-Saint-Lambert	Belgium
Iamjoy	Bonheiden	Belgium
Czubst Hjywpclonip Rmmljvsp Sfeulo ey Mxyij	Namur	Belgium
Uzphlmmpnx Ou Afswxfk	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	10.11.2022

Trial locations

Investigated drugs:

5-FU (Fluorouracil) is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell growth and division. In this trial, it serves as a backbone treatment combined with other medications.

Naliri is an investigational drug being studied in combination with 5-FU for treating pancreatic cancer in patients whose disease has progressed after previous treatment.

Nalirinox is another investigational treatment combination being studied for pancreatic cancer. It is used in combination with 5-FU for patients whose disease has progressed after previous treatment.

Gemcitabine is a chemotherapy medication that was used in the patients’ previous treatment. It works by preventing cancer cells from making and repairing DNA, which stops them from growing and dividing.

Abraxane (also known as nab-paclitaxel) is a chemotherapy medication that was previously used in combination with gemcitabine. It works by stopping cancer cells from dividing and growing.

Investigated diseases:

Ductal adenocarcinoma of pancreas

Metastatic Pancreatic Ductal Adenocarcinoma – A type of pancreatic cancer that begins in the ducts that carry digestive enzymes and has spread to other parts of the body. The disease starts in the cells lining the pancreatic ducts and grows to form a tumor that can invade nearby tissues. This form of cancer develops when cells in the pancreatic ducts begin to multiply uncontrollably and form masses. The metastatic stage means the cancer cells have spread beyond the pancreas to other organs, commonly the liver, lungs, or nearby lymph nodes. The disease typically affects the body’s ability to produce digestive enzymes and hormones that regulate blood sugar.

Trial ID:

2024-516336-97-00

Protocol code:

NALPAC

NCT ID:

NCT05472259

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of fluorouracil, irinotecan and oxaliplatin combination therapy for patients with metastatic pancreatic ductal adenocarcinoma who progressed after gemcitabine treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?