Study on the Effectiveness of Paclitaxel and Gemcitabine for Patients with Pancreatic Cancer Spread to the Abdomen

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What is this study about?

This clinical trial is focused on studying pancreatic cancer that has spread to the lining of the abdomen, known as peritoneal metastases. The trial is testing a combination of treatments to see how effective they are in controlling the cancer. The treatments being used in this study include Nabpaclitaxel and Gemcitabine. Nabpaclitaxel is given in two ways: as a pressurized aerosol directly into the abdomen, and as a systemic treatment, which means it is given through the bloodstream. Gemcitabine is also given systemically. The purpose of the study is to evaluate how well these combined treatments work in controlling the cancer.

Participants in the study will receive these treatments over a period of up to 12 months. The study will monitor how the cancer responds to the treatment, looking for signs of complete or partial response, or if the disease remains stable for at least 16 weeks. The study will also assess the safety of the treatments and any side effects that may occur. Participants will undergo regular assessments to track their progress and any changes in their condition.

The trial aims to gather information on the effectiveness of the treatment combination and its impact on the quality of life for those with pancreatic cancer that has spread to the peritoneum. The study will also explore various aspects of the treatment, such as how the drugs are absorbed in the body and their effects on the cancer cells. This research could provide valuable insights into new ways to manage and treat this type of cancer.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure all criteria are met.

2 treatment cycle 1

The first treatment cycle begins with the administration of gemcitabine and paclitaxel through an intravenous route. The specific dosage and frequency are determined by the medical team based on individual health status.

In addition, paclitaxel is administered using a method called pressurized intraperitoneal aerosol chemotherapy (PIPAC), which involves delivering the medication directly into the abdominal cavity.

3 monitoring and evaluation

Throughout the treatment, regular monitoring is conducted to assess the response to the therapy. This includes imaging tests and laboratory evaluations to track the progress of the disease.

The effectiveness of the treatment is measured using criteria that evaluate the size and spread of the cancer.

4 subsequent treatment cycles

The treatment plan includes multiple cycles of the combined chemotherapy. Each cycle involves the administration of the same medications, with adjustments made as necessary based on the patient’s response and any side effects experienced.

The goal is to complete six cycles of systemic chemotherapy combined with three PIPAC cycles, with evaluations conducted after each cycle.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is performed to determine the overall response to the therapy. This includes imaging tests and other assessments to measure the disease control rate.

The final results are compared to the initial assessments to evaluate the effectiveness of the treatment.

6 follow-up

After completing the treatment, follow-up visits are scheduled to monitor long-term outcomes and manage any ongoing side effects. These visits help ensure any changes in health status are promptly addressed.

Who Can Join the Study?

Must be at least 18 years old.
Must have adequate bone marrow function, which means:
- Enough white blood cells (absolute neutrophil count ≥ 1500 cells/mm³).
- Enough platelets (≥ 100,000 cells/mm³).
Must have a hemoglobin level of at least 9 g/dl. Hemoglobin is a protein in red blood cells that carries oxygen.
Must have adequate kidney function. This is checked by measuring a substance called creatinine in the blood.
Any side effects from previous treatments or surgeries must be mild (Grade ≤ 1), except for hair loss or nerve damage in the hands and feet.
If there are no liver metastases, liver enzymes (ALT and AST) should be below 2.5 times the normal limit. If there are liver metastases, these enzymes should be less than 5 times the normal limit.
Total bilirubin should be within normal limits, or slightly higher if you have a condition called Gilbert’s Syndrome.
If initial blood tests are abnormal, they can be repeated up to two times, and you may receive supplements before retesting.
Women who can have children must have a negative pregnancy test within 72 hours before starting the study treatment.
Men must agree to use effective birth control methods, such as condoms, during the study and for 120 days after the last dose of study drugs. If their partner can have children, additional birth control methods should be used.
Must be willing and able to provide written informed consent, which means you agree to participate in the study after understanding all the details.
Must have a confirmed diagnosis of pancreatic cancer.
Must have pancreatic cancer that has spread to the peritoneum (the lining of the abdomen), confirmed by a doctor using imaging tests or surgery.
Must have a disease that can be measured according to specific criteria (RECIST 1.1).
Must have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
Must have a life expectancy of at least 3 months.
Must not have any medical reasons that prevent you from having a laparoscopy, a type of surgery that looks inside the abdomen.
Must not have any medical reasons that prevent you from taking the drugs used in the study.

Who Cannot Join the Study?

Patients who do not have pancreatic cancer with peritoneal metastases cannot participate. This means the cancer has spread from the pancreas to the lining of the abdomen.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	08.11.2021

Trial locations

Investigated drugs:

Nabpaclitaxel is a type of chemotherapy drug used in this trial. It works by stopping cancer cells from dividing and growing, which can help to slow down or stop the spread of cancer. In this study, Nabpaclitaxel is used in two ways: as a pressurized aerosol directly into the abdomen and as part of a systemic treatment, which means it is given to affect the whole body.

Gemcitabine is another chemotherapy medication used in this trial. It helps to kill cancer cells by interfering with their DNA, which is necessary for them to grow and multiply. In this study, Gemcitabine is used alongside Nabpaclitaxel as part of the systemic treatment to help treat pancreatic cancer that has spread to the lining of the abdomen.

Investigated diseases:

Pancreatic carcinoma

Pancreatic cancer with peritoneal metastases – Pancreatic cancer is a type of cancer that begins in the tissues of the pancreas, an organ in the abdomen that lies behind the lower part of the stomach. When it spreads to the peritoneum, the thin layer of tissue lining the abdomen, it is referred to as peritoneal metastases. This progression occurs when cancer cells break away from the primary tumor in the pancreas and travel through the bloodstream or lymphatic system to the peritoneum. The presence of cancer in the peritoneum can lead to symptoms such as abdominal pain, bloating, and changes in bowel habits. As the disease progresses, it can cause fluid accumulation in the abdomen, known as ascites, and may affect the function of nearby organs. The spread of cancer to the peritoneum often indicates an advanced stage of the disease.

Trial ID:

2024-518938-81-00

Protocol code:

Nab-PIPAC

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Paclitaxel and Gemcitabine for Patients with Pancreatic Cancer Spread to the Abdomen

What is this study about?

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