Not recruiting

Study of Ramucirumab and Dacarbazine for Patients with Progressive Metastatic Pancreatic Neuroendocrine Tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as progressive well-differentiated metastatic neuroendocrine tumors of the pancreas. These are tumors that originate in the hormone-producing cells of the pancreas and have spread to other parts of the body. The study is investigating the effects of a treatment combination that includes ramucirumab, also known by its code name LY3009806, and dacarbazine. Ramucirumab is a medication given through an infusion into the vein, and it works by blocking the blood supply to the tumor, potentially slowing its growth.

The purpose of this study is to explore whether the combination of ramucirumab and dacarbazine can help control the disease in patients with these specific pancreatic tumors. Participants in the study will receive the treatment and be monitored over a period to assess how their disease responds. The study will look at various outcomes, including how well the tumors respond to the treatment, how long patients live without the disease getting worse, and the overall survival of the patients. Additionally, the study will evaluate the side effects of the treatment and its impact on the patients' quality of life.

Throughout the study, researchers will also conduct additional tests to understand more about the disease and the treatment's effects. This includes looking at certain proteins and markers in the blood that might predict how well the treatment works. The study aims to provide valuable information that could lead to better treatment options for patients with this type of pancreatic cancer in the future.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood tests and imaging studies may be performed to ensure the condition meets the study criteria.
Step 2
Treatment initiation
The treatment involves the administration of ramucirumab and dacarbazine. Ramucirumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.
The dosage and frequency of administration are determined by the study protocol and will be explained by the healthcare team.
Step 3
Ongoing treatment
Regular visits to the clinic are required for the administration of the medications and monitoring of health status.
During these visits, blood tests and other assessments may be conducted to monitor the response to treatment and any side effects.
Step 4
Mid-study evaluation
After six months, an evaluation is conducted to assess the disease control rate. This involves imaging studies and other tests to determine the effect of the treatment on the condition.
The healthcare team will discuss the results and any necessary adjustments to the treatment plan.
Step 5
Completion of study
At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of the treatment's impact on the condition and overall health.
Participants may be asked to complete a questionnaire about their quality of life during the study.

Who can join the trial?

9 criteria

Must have a confirmed diagnosis of a metastatic neuroendocrine tumor of the pancreas that cannot be removed by surgery. This includes both non-functional and functional tumors, but not neuroendocrine carcinomas.
Age between 18 and 75 years.
Must have a tumor that can be measured using specific medical criteria (RECIST 1.1).
The disease must be getting worse despite treatment with certain medications, but not with DTIC or temozolomide. Previous treatments like TACE and SIRT are allowed if done at least 3 months before joining the study, and PRRT if done at least 12 months before.
Must have an ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of more than 12 weeks.
Must have adequate kidney, liver, bone marrow, and blood clotting function.
If sexually active, must be postmenopausal, surgically sterile, or using effective birth control. Female participants who can become pregnant must have a negative pregnancy test within 7 days before starting the study treatment.
Must provide written informed consent to participate in the study.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not related to the pancreas cannot participate.
Patients who have had another cancer in the past, unless it was treated and has not come back for at least 5 years, are excluded.
Patients who have had a heart attack or stroke in the last 6 months cannot join the study.
Patients with uncontrolled high blood pressure, which means blood pressure that is not managed well with medication, are not eligible.
Patients with serious infections that require treatment with antibiotics, antivirals, or antifungals are excluded.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have had major surgery within the last 4 weeks are not eligible.
Patients with a history of bleeding disorders, which are conditions that affect the way blood clots, are excluded.
Patients who are currently participating in another clinical trial cannot join this study.
Patients with known allergies to the study drugs or similar drugs are not eligible.

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Verified sites

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

Martin-Luther-Universitaet Halle-Wittenberg
Verified
Halle (Saale), Germany
Philipps-Universitaet Marburg
Verified
Marburg, Germany
Universitaetsklinikum Heidelberg AöR
Verified
Heidelberg, Germany

Trial locations

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Investigated drugs

Ramucirumab
is a medication used in this clinical trial to help control the growth of tumors. It works by blocking a specific protein that tumors need to grow new blood vessels. By stopping the formation of these blood vessels, ramucirumab can help slow down or stop the growth of the tumor.
Dacarbazine
is another medication used in this trial. It is a type of chemotherapy that works by interfering with the DNA of cancer cells, which can prevent them from growing and dividing. This helps to control the spread of the cancer and can reduce the size of the tumors.

Ramucirumab

What is already known about the treatment

Ramucirumab
Ramucirumab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in combination with dacarbazine for its potential to help control disease in patients with progressive pancreatic neuroendocrine tumors. This medication works by blocking a specific protein that helps blood vessels grow, which can slow down or stop the growth of tumors. Ramucirumab is classified as a monoclonal antibody, a type of targeted cancer therapy.
Dacarbazine
Dacarbazine is given as an intravenous injection, which means it is delivered directly into the bloodstream through a vein. It is being tested in combination with ramucirumab to see if it can help manage progressive pancreatic neuroendocrine tumors. Dacarbazine works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading. It is classified as an alkylating agent, a type of chemotherapy drug.

Investigated diseases

Progressive well-differentiated metastatic neuroendocrine tumors of the pancreas – These tumors originate from neuroendocrine cells in the pancreas, which are responsible for producing hormones. They are characterized by their ability to grow slowly and maintain some features of normal cells, which is referred to as being well-differentiated. As the disease progresses, these tumors can spread to other parts of the body, a process known as metastasis. The progression of the disease can lead to an increase in tumor size and number, potentially affecting the function of the pancreas and other organs. Symptoms may vary depending on the hormones produced by the tumor and the organs affected by metastasis. The disease's progression is typically monitored through imaging studies and biochemical markers.