A trial comparing nintedanib to chemotherapy for clear cell cancer of the ovary or lining of the womb (NiCCC)

Cancer type:

Ovarian cancer
Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Phase 2

This trial is comparing nintedanib to chemotherapy for clear cell cancer of the ovary or womb that has either grown or come back after earlier chemotherapy. This trial is supported by Cancer Research UK.

More about this trial

Clear cell cancer is a rare type of cancer. If it starts in the ovary or the lining of the womb (endometrium), doctors often treat it with surgery followed by chemotherapy. But sometimes the cancer can continue to grow or come back after treatment. In this situation chemotherapy is not always helpful and so researchers are looking for new treatments. In this trial they are looking at a drug called nintedanib (pronounced nin-ted-a-nib).

Nintedanib (also known as BIBF1120) is a biological therapy. It stops cancer cells forming blood vessels that they need in order to grow. Researchers want to see if nintedanib is a better treatment for clear cell cancer than chemotherapy. The aims of the trial are to

  • See how long nintedanib controls the cancer compared to chemotherapy
  • Compare the side effects of nintedanib and chemotherapy
  • See how the 2 treatments affect your day to day life

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have  clear cell cancer of your ovary or lining of your womb (endometrium) that got worse during treatment or came back afterwards
  • Have had  at least 1 type of chemotherapy that contained a platinum drug Open a glossary item (if you have ovarian clear cell cancer, it must have come back within 6 months of finishing platinum chemotherapy)
  • Are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • Have satisfactory blood test results
  • Are willing to use contraception during the trial and for up to 3 months afterwards if there is any possibility you could become pregnant
  • Are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have already had nintedanib or any similar drug apart from bevacizumab
  • Have had chemotherapy or biological therapy in the last 4 weeks
  • Have had chemotherapy that included any of the same combination of drugs being used in the trial. If you have had paclitaxel (Taxol) you may be able to take part (the trial team can advise you about this)
  • Have had radiotherapy in the last 4 weeks unless it was for pain control for cancer spread to the bones
  • Have had hormone therapy, an experimental drug or immunotherapy in the last 4 weeks
  • Have not recovered fully from any surgery you’ve had in the last 4 weeks, or you have some surgery planned during the time of the trial
  • Have had any other cancer in the past 5 years apart from very early stage cancer (carcinoma in situ Open a glossary item)  of the cervix or  breast, or non melanoma skin cancer that was successfully treated
  • Have clear cell ovarian cancer and have previously had cancer of the lining of the womb (either before your ovarian cancer diagnosis or at the same time) unless it was stage 1a and grade 1 or 2 and was successfully treated
  • Have cancer that has spread to your spinal cord or brain
  • Have a tumour that on a scan looks like it has died or shows a hollowed out area within a shell of cancer tissue (cavitation), and it has grown into major blood vessels Open a glossary item
  • Have had a heart attack in the last 6 months or have certain other heart problems (the trial doctors can advise you about this)
  • Have had a stroke, a mini stroke (TIA), or any bleeding in your brain in the last 6 months
  • Have ever had a blood clot in your lung or leg (if this has happened, but you are taking medication to thin your blood, you may be able to take part)
  • Have had major bleeding (a haemorrhage) in the last 6 months
  • Have a condition which means you are more likely to bleed (bleeding disorder)
  • Have had any major injuries in the last 4 weeks and have not fully recovered
  • Are allergic to any of the drugs used in the trial (your doctors can advise you about this)
  • Are allergic to peanuts or soya
  • Have any condition which would stop you swallowing or absorbing tablets
  • Have HIV, hepatitis B or hepatitis C, or any other infection that needs treatment
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 120 women to take part. They need 90 women with clear cell cancer of the ovary and up to 30 women with clear cell cancer of the lining of the womb (endometrium).  It is a randomised trial. The women taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone taking part will be put into 1 of 2 treatment groups. Women in one group will have nintedanib. Women in the other group will have chemotherapy.

The chemotherapy used is the standard treatment Open a glossary item given to women with clear cell ovarian or womb cancer that has come back. The chemotherapy drugs you have will depend on whether you have ovarian cancer or womb cancer and also on what drugs the doctors think will work best for you. They will discuss this with you.

If you have ovarian cancer, you will have one of the following

  • Nintedanib
  • Paclitaxel (Taxol)
  • Topotecan
  • Pegylated Liposomal doxorubicin (Pegylation Open a glossary item is a way of treating drugs to change the way they behave in your body. This may help doxorubicin stay in your bloodstream longer so that more of it reaches the cancer cells)

Nintedanib is a capsule that you swallow. If you are in the nintedanib group, you take it twice a day for as long as it is working and you can manage any side effects. The trial team will give you a diary to record when you take the nintedanib. They will ask you to take this to all your hospital visits.

You have chemotherapy through a drip into a vein. If you are in the chemotherapy group, you have 4 week cycles of treatment. Depending on the chemotherapy drug you have, each treatment cycle consists of

  • Paclitaxel once a week for 3 weeks and then 1 week without treatment
  • Topotecan once a week for 3 weeks and then 1 week without treatment
  • Liposomal doxorubicin once every 4 weeks

In total you will have 6 cycles of treatment.

If you have womb cancer you will have one of the following

If you are in the nintedanib group, you have it as described above.

If you are in the chemotherapy group, you have 3 week cycles of treatment. You have one of the following

  • Carboplatin and paclitaxel through a drip into a vein once every 3 weeks
  • Doxorubicin through a drip into a vein once every 3 weeks

In total you will have up to 6 cycles of treatment.

The trial team will ask you to fill out a few questionnaires when you start treatment. If you are having chemotherapy they will ask you to complete the questionnaires before each cycle of treatment and then every 2 months. If you are having nintedanib they will ask you to complete these every month for 6 months. These questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study. The trial team will ask you to complete the questionnaires for as long as you are happy to or until you are no longer taking part in the trial.

The trial team may ask you to take part in some additional research. This involves agreeing to have some extra blood tests, and also to having another sample (biopsy) of your cancer taken.

The researchers will also request a sample of your cancer taken during any previous surgery. The blood and biopsy samples will be used in the laboratory to help doctors to understand how the cancer develops, why some cancers come back after treatment and who would benefit most from nintedanib or chemotherapy.  This is called translational research. You don’t have to take part in this research if you don’t want to, you can still take part in the trial.

Hospital visits

You see the doctor and have some tests before taking part. These tests include

If you are having chemotherapy you will need to go to hospital for each treatment. The length of time you are there will vary according to the drugs you have but you should not need to stay overnight. You will see the doctor and have some blood tests before each treatment.

If you are having nintedanib you will go to hospital to see the doctors every month for 6 months. For the first 5 weeks you will have weekly blood tests.

After you have finished your treatment you will see the doctors about a month later. You will then be seen every 2 months until either your cancer gets worse or you choose to leave the trial.

Everybody taking part in the trial will have a CT scan every 2 months for up to a year. You will also have regular blood tests.

Side effects

Nintedanib is a new drug and there may be some side effects we don’t know about yet. The most common side effects include

The most common side effects of topotecan are

The most common side effects of liposomal doxorubicin are

  • A drop in blood cells causing an increased risk of infection, bleeding or bruising, tiredness and shortness of breath
  • Feeling or being sick
  • Constipation
  • Damage to your heart muscle
  • A sore mouth or mouth ulcers
  • Hot flushes
  • Changes to your skin such as an itchy rash
  • Backache
  • Soreness, redness and peeling skin on the palms of your hands and soles of your feet (hand-foot or palmar plantar syndrome)

The most common side effects of doxorubicin are

  • A drop in blood cells causing an increased risk of infection, bleeding or bruising, tiredness and shortness of breath
  • Feeling or being sick
  • Hair loss
  • A sore mouth and throat
  • Sensitivity to sunlight
  • Loss of fertility (ability to have a child).
  • Damage to heart muscle
  • Constipation

The most common side effects of paclitaxel are

  • A drop in blood cells causing an increased risk of infection, bleeding or bruising, tiredness and shortness of breath
  • Hair loss
  • Numbness or tingling in your fingers and toes
  • A sore mouth or mouth ulcers
  • Aching joints or muscles
  • Tiredness
  • You may feel a bit tipsy because the paclitaxel drip contains alcohol to help dissolve the drug – it is the equivalent of a large glass of wine or a pint of beer

We have more information about

Location

Belfast
Bristol
Cardiff
Dundee
Glasgow
Kent
Leeds
Liverpool
London
Manchester
Sutton
Taunton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Rosalind Glasspool

Supported by

Boehringer Ingelheim
Cancer Research UK
European Organisation for Research and Treatment of Cancer
Experimental Cancer Medicine Centre (ECMC)
Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
Nordic Society of Gynaecological Oncology
Scottish Gynaecological Cancer Trials Group

Other information

This is Cancer Research UK trial number CRUKE/12/024.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9542

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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