CompletedPhase IIInterventional

Does cediranib together with paclitaxel chemotherapy, or cediranib and olaparib, treat advanced endometrial cancer better than paclitaxel chemotherapy?

This Phase II clinical trial looks at new ways to treat advanced or recurrent womb (endometrial) cancer. When womb cancer returns after initial chemotherapy, standard care usually involves a chemotherapy medicine called paclitaxel. Doctors want to find out if adding newer, targeted drugs can improve treatment results. The trial compares three approaches: paclitaxel alone, paclitaxel combined with a targeted drug called cediranib, or two targeted drugs together (cediranib and olaparib) without standard chemotherapy. Cediranib works by cutting off the blood supply that tumours need to grow, while olaparib prevents cancer cells from repairing their damaged DNA. Researchers hope to learn whether these new combinations can control the cancer for longer and help women live better and longer lives. The trial is open to women aged 16 and over whose cancer has come back after earlier platinum-based chemotherapy.

At a glance

Status

Completed

Phase

Phase II

Sponsor

University of Manchester

Enrolment target

129

Start

12 Feb 2018

Estimated completion

31 Dec 2021

Advanced/metastatic endometrial cancer

What is this study about?

Womb cancer (also known as endometrial cancer) starts in the lining of the womb. In many cases, it is caught early and treated successfully with surgery. However, in some women, the cancer can spread to other parts of the body (advanced cancer) or return after initial treatment (recurrent cancer). When this happens, doctors usually offer chemotherapy to keep the disease under control, but better options are urgently needed.

This study tests whether newer, targeted cancer medicines work better than standard chemotherapy alone. Targeted therapies are designed to attack specific weaknesses inside cancer cells, which can stop them growing while causing different side effects to traditional chemotherapy. The trial investigates two targeted medicines: cediranib, which blocks tumours from creating blood vessels to feed themselves, and olaparib, which stops cancer cells from fixing their own DNA.

Participants in this study are placed into one of three treatment groups at random. One group receives the usual weekly paclitaxel chemotherapy. The second group receives paclitaxel along with daily cediranib tablets. The third group takes daily tablets of both cediranib and olaparib together, without paclitaxel. Comparing these three groups helps doctors see whether the targeted drug combinations are safer and more effective than standard treatment.

Key takeaways

This trial is testing targeted drugs (cediranib and olaparib) against standard chemotherapy for advanced womb cancer.
It aims to see if these new combinations keep the cancer under control for longer.
Participants are randomly assigned to one of three different treatment groups.
The study is for women whose cancer has returned after previous platinum chemotherapy.
Taking part is voluntary, and you can stop at any time without affecting your normal care.

Who may be eligible?

You may be able to join this trial if you are a woman aged 16 or over with advanced or recurrent womb cancer (endometrial cancer or carcinosarcoma) that can be clearly measured on a CT scan. You must have already had one course of platinum-based chemotherapy, and your cancer has either grown during treatment or returned within 12 months of finishing it.

To take part safely, your body needs to be strong enough for the treatments. This means having satisfactory blood test results, including healthy liver, kidney, and bone marrow function. You also need to be up and about for at least half of your waking hours, have a well-controlled thyroid, and be able to swallow tablets whole.

You will not be able to take part if you are unable to stop taking certain herbal remedies or supplements, as these can interfere with trial medicines. Your medical team will also check your heart, blood pressure, and protein levels in your urine to ensure that the study drugs are safe 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.

I am a woman aged 16 or over.
I have advanced or recurrent womb cancer (endometrial cancer or carcinosarcoma).
I have had platinum-based chemotherapy in the past, and my cancer has returned.
I am able to walk and look after myself for most of the day.
I can swallow tablets whole.
I am willing to stop taking herbal remedies and supplements.

Answer every question to see your result.

What does participation involve?

Taking part involves regular hospital visits for check-ups and treatment. If you receive paclitaxel, it is given as a drip into a vein once a week. If you receive cediranib or olaparib, you will take these as daily tablets at home. Throughout the trial, you will have routine blood tests, urine tests, blood pressure checks, and CT scans every few weeks to monitor your health and see how the cancer is responding. You will also be asked about any symptoms or side effects you experience. The treatment continues for as long as it helps keep your cancer under control and you do not experience severe side effects. Afterward, the research team will keep in touch to check on your long-term health.

Potential risks and benefits

Taking part may help slow down your cancer and ease symptoms, and the information gathered will help improve care for future patients. However, there is no guarantee that these new drug combinations will work better than standard treatment. All cancer medicines carry a risk of side effects; paclitaxel can cause nerve tingling, hair loss, and fatigue, while cediranib and olaparib can cause high blood pressure, sickness, or tiredness. Your team will monitor you closely and give you treatments to help manage any side effects. Taking part is completely voluntary, and you can leave the study at any time without your regular care being affected.

Locations (15)

The Christie NHS Foundation Trust
City only
Manchester, England
University College London Hospital
City only
London, England
Mount Vernon Cancer Centre
City only
Northwood, England
Velindre Cancer Centre
Approximate
Cardiff, Wales
Bristol Haematology & Oncology Centre
Approximate
Bristol, England
Churchill Hospital
Unverified
Oxford, England
The Royal Marsden Hospital (Surrey)
Unverified
Sutton, England
The Royal Marsden Hospital
Unverified
London, England
Beatson West of Scotland Oncology Centre
Unverified
Glasgow, Scotland
Northern Centre for Cancer Care
Unverified
Newcastle upon Tyne, England
Royal Surrey County Hospital
Unverified
Guildford, England
Leicester Royal Infirmary
Unverified
Leicester, England

Common questions

Can I choose which treatment group I am in?

No. A computer assigns you to one of the three treatment groups at random. This makes sure the trial results are completely fair and unbiased.

Do I have to pay for the trial drugs?

No. In the UK, clinical trial medicines and any additional trial-related tests are provided free of charge through the NHS.

Why do I have to stop taking herbal supplements?

Certain herbal supplements can change how your body breaks down cancer medicines, which can make the drugs less effective or increase harmful side effects.

Can I leave the trial if I change my mind?

Yes. You can leave the trial at any time for any reason. Your standard NHS care will continue as normal, and your doctors will discuss other options with you.

Will I lose my hair during this study?

Paclitaxel chemotherapy commonly causes hair thinning or hair loss. The targeted tablet combination (cediranib and olaparib) does not usually cause complete hair loss, although minor thinning can still happen.

How to find out more

Clare Freestone

COPELIA@cardiff.ac.uk +44(0)29 20687095 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.