Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A multicenter single-arm pilot study of ramucirumab in combination with dacarbazine in patients with progressive well differentiated metastatic pancreatic neuroendocrine tumors

This study is testing a new way to treat well-differentiated metastatic pancreatic neuroendocrine tumours, which is a type of pancreatic cancer that has spread to other parts of the body. The treatment involves a medicine called Cyramza (ramucirumab) given alongside dacarbazine, a chemotherapy drug that's already used. We want to find out how well this combination helps control the cancer for at least six months. This is a small, early-stage study (Phase II) to see if this treatment shows promise for patients whose cancer is progressing, meaning it's growing or getting worse. We will also check for side effects and how it affects patients' quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Martin-Luther-Universitaet Halle-Wittenberg

Enrolment target

Start

11 Oct 2024

Progressive well-differentiated metastatic neuroendocrine tumors of the pancreas

What is this study about?

This study is an important step in finding better treatments for a specific type of cancer called well-differentiated metastatic pancreatic neuroendocrine tumours. These are special kinds of tumours that start in the pancreas and have spread to other areas of the body. The word 'well-differentiated' means the cancer cells still look quite similar to normal cells, and 'metastatic' means the cancer has spread.

The main goal of this study is to see if combining a newer medicine called Cyramza (ramucirumab) with a standard chemotherapy drug called dacarbazine can effectively control the cancer's growth for at least six months. 'Controlling the cancer's growth' means stopping it from getting bigger or spreading further. We'll also be looking at how much the tumours shrink, how long people live without their cancer getting worse, and how long they live overall. Another important part of the study is to understand any side effects the treatment might have and how it affects a patient's daily life and well-being, which we call their 'quality of life.'

This is a 'Phase II' study, which means it's an early but crucial step in testing new treatments. It's too soon to say if this treatment will become standard, but by taking part, patients help doctors learn if this combination has a good chance of being an effective and safe option in the future. The findings from this study will help guide larger studies if the results are promising.

Key takeaways

It's a study for a specific, spreading pancreatic cancer.
It tests Cyramza combined with chemotherapy (dacarbazine).
Doctors want to see if the cancer can be controlled for at least 6 months.
It will also look at side effects and quality of life.
This is an early-stage study to find new treatment options.

Who may be eligible?

This study is designed for adults aged 18 and over. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.

To be considered for the study, you must have a specific type of pancreatic cancer called 'progressive well-differentiated metastatic neuroendocrine tumours of the pancreas.' 'Progressive' means your cancer is currently growing or getting worse. 'Well-differentiated' describes the type of cancer cells, and 'metastatic' means the cancer has spread from the pancreas to other parts of your body.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a type of pancreatic cancer called 'well-differentiated metastatic neuroendocrine tumour'?
Is your cancer currently showing signs of progression (growing)?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, which is a combination of Cyramza and dacarbazine, given as an infusion into your vein. You will need to attend regular hospital appointments for these treatments and for check-ups. These appointments will involve physical examinations, blood tests, and scans (like CT or MRI scans) to monitor your cancer and assess how you are responding to the treatment.

The research team will also ask you to complete questionnaires to understand how the treatment is affecting your daily life and well-being. These might include questions about your energy levels, pain, and general feelings. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment combination that might help control your cancer. However, as with any medical treatment, there are potential risks and side effects from the drugs being tested. The study team will carefully monitor you for these and will explain them all in detail before you make any decision. You are always in control and have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What kind of cancer is this study for?

This study is for a specific type of pancreatic cancer that has spread to other parts of the body and is currently growing. It's called 'well-differentiated metastatic pancreatic neuroendocrine tumours'.

What is Cyramza and dacarbazine?

Cyramza (ramucirumab) is a newer medicine, and dacarbazine is a chemotherapy drug already used to treat some cancers. This study explores them together.

What does 'disease control rate' mean?

It means how many patients in the study have their cancer stabilised or shrinking, rather than growing, for a period of at least six months.

Will I get better if I join this study?

We cannot guarantee you will get better. This is a research study to see if a new treatment works, and like all medical treatments, there's no certainty of the outcome. However, your doctors will closely monitor your health.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.