Active not recruitingPHASE2INTERVENTIONAL

Pazopanib Vs. Pazopanib Plus Gemcitabine

This research study is for women with advanced forms of womb cancer, specifically uterine leiomyosarcoma or uterine carcinosarcoma, that has come back or spread. The main goal is to find out if combining two cancer drugs, pazopanib and gemcitabine, is more effective at stopping the cancer from growing or spreading compared to using pazopanib alone. Participants with leiomyosarcoma will be randomly split into two groups, receiving either the single drug or the combination. Those with carcinosarcoma will all receive the combination treatment. This is a Phase 2 study, meaning it's an earlier stage trial to see if the treatment is safe and shows promise before larger studies are done. It aims to improve treatment options for these rare cancers.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

North Eastern German Society of Gynaecological Oncology

Enrolment target

Start

16 Oct 2019

Estimated completion

31 Dec 2024

Leiomyosarcoma or Carcinosarcoma

What is this study about?

This study is a research project looking into new ways to treat two specific types of womb (uterine) cancer: leiomyosarcoma and carcinosarcoma. These cancers can be challenging to treat, especially if they have spread to other parts of the body or have come back after previous treatments. The medical team leading this study wants to find the best way to help patients whose cancer is in this situation.

The study will compare two different treatment approaches. One approach uses a medicine called pazopanib on its own. The other approach combines pazopanib with another anti-cancer medicine called gemcitabine. The main question the researchers want to answer is whether the combination of these two drugs can keep the cancer under control for longer than pazopanib alone. This is measured by something called 'progression-free survival', which means the length of time a person lives without their cancer getting worse.

This is a 'Phase 2' study, which means it's an early-stage trial. These trials are important because they help doctors understand if a new treatment or combination of treatments is safe and shows good results before they can be tested in even larger groups of people. The results from this study could help improve future treatments for women with these specific womb cancers.

Key takeaways

This study explores new treatments for advanced uterine leiomyosarcoma and carcinosarcoma.
It compares pazopanib alone versus pazopanib plus gemcitabine.
The main goal is to see which treatment controls cancer for longer.
You will receive daily tablets and/or intravenous (IV) infusions.
Regular hospital visits for checks and tests are part of participation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and a woman diagnosed with either uterine leiomyosarcoma or uterine carcinosarcoma. Your cancer should have either returned after previous treatment or spread to other parts of your body.

There are also some requirements about your general health. For example, your heart should be working well, especially if you've had certain types of chemotherapy before. Your other important organs like your liver, kidneys, and blood system also need to be functioning within healthy ranges. You must be able to swallow tablets or capsules, as one of the study drugs is taken by mouth.

It's important that your overall health lets you manage daily activities, and you should be willing to follow the study plan carefully and attend all appointments. The medical team will check all these details to make sure the study is a safe and suitable option for you.

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 at least 18 years old?
Do you have uterine leiomyosarcoma or uterine carcinosarcoma?
Has your cancer spread or come back after previous treatment?
Do you have generally good health and organ function (e.g., heart, liver, kidneys)?
Can you swallow tablets or capsules easily?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is to carefully read and understand the study information and sign a consent form. This makes sure you know exactly what's involved. All participants will receive treatment, but the exact drugs you get will depend on your specific cancer type.

If you have uterine leiomyosarcoma, you will be randomly placed into one of two groups: one group will receive pazopanib as a daily tablet, and the other group will receive pazopanib daily plus gemcitabine given into a vein on specific days every three weeks. If you have uterine carcinosarcoma, you will receive the combination of pazopanib daily and gemcitabine on specific days every three weeks.

Throughout the study, you will have regular visits to the hospital for blood tests, scans, and check-ups to see how you are doing and how the treatment is working. These tests will also monitor for any side effects. You will continue with the treatment for as long as it benefits you and your cancer doesn't get worse, or until side effects become too difficult to manage, or you decide to stop for any reason.

Potential risks and benefits

Before deciding, it's important to weigh the possible benefits and risks. The potential benefit of participating is that you might receive a treatment that is more effective at controlling your cancer, potentially helping you live longer without your cancer getting worse. However, this is not guaranteed, and the study aims to find out if one treatment is better than the other. All medicines have potential side effects, and both pazopanib and gemcitabine can cause various side effects, which the study team will discuss with you in detail. There will be regular checks to monitor your health and manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Universitätsklinikum Bonn
Verified postcode
Bonn, Germany
Helios Klinikum Berlin-Buch, Klinik für Onkologie und Paliativmedizin
Verified postcode
Berlin, Germany
Universitätsmedizin Greifswald Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Verified postcode
Greifswald, Germany
Helios Klinikum Bad Saarow, Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum
Verified postcode
Bad Saarow, Germany
Universitätsmedizin Berlin Charité Campus Virchow-Klinikum
Verified postcode
Berlin, Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden Klinik für Frauenheilkunde und Geburtshilfe
Verified postcode
Dresden, Germany
Kliniken-Essen-Mitte Evang. Huyssens-Stiftung Klinik für Senologie / Brustzentrum
Verified postcode
Essen, Germany
Universitätsklinikum Jena
Verified postcode
Jena, Germany
Universitätsfrauenklinik Tübingen
Verified postcode
Tübingen, Germany

Common questions

What is 'progression-free survival'?

This is simply the length of time that a patient lives without their cancer getting worse or spreading further.

What does 'randomized' mean?

It means participants are put into treatment groups by chance, like flipping a coin. This helps make the study fair and scientific.

What are leiomyosarcoma and carcinosarcoma?

They are both rare types of cancer that start in the womb (uterus). They are different from the more common types of womb cancer.

Are the drugs pazopanib and gemcitabine new?

No, both pazopanib and gemcitabine are established cancer drugs, but this study is looking at using them in a new combination for these specific types of womb cancer.

What does Phase 2 study mean?

It's an early stage of clinical research. It mainly checks if a new treatment is safe and shows promise, before larger studies are done.