Trial Summary

A trial looking at standard treatment with or without cediranib for ovarian, fallopian tube or primary peritoneal cancer that has come back (ICON 6)

This trial is comparing standard treatment and a new treatment blocking blood vessel growth, with standard treatment alone for ovarian, fallopian tube or primary peritoneal cancer that has come back (recurred). The new treatment is called cediranib, Recentin or AZD2171.

Sometimes ovarian cancer starts to grow again after it was first treated. If this happens, it can be more difficult to treat successfully. Many women have carboplatin and paclitaxel (Taxol) to treat ovarian cancer that has come back. However the type of chemotherapy you have depends on your individual case. There may be other chemotherapy drugs that might work better for you such as gemcitabine and carboplatin, or treatment with carboplatin or cisplatin alone. 

For a cancer to grow, it needs its own blood supply to develop. Doctors call this growth of blood vessels ‘angiogenesis’. Cediranib is a new type of biological therapy. It blocks the cancer from developing its own blood supply and this may help to slow or stop cancer growth. This is called anti-angiogenic treatment.

Doctors are not sure yet how well cediranib will work with chemotherapy for women with ovarian cancer.

The aims of the trial are to find out

  1. If this combination of drugs is safe in women with ovarian cancer
  2. If cediranib and chemotherapy together are better at slowing or stopping cancer growth than chemotherapy alone
  3. How long women should have cediranib for
  4. More about side effects and how this affects quality of life

Recruitment

Start 29/11/2007
End December 2011

Phase

Phase 2/3

Who can enter

You can enter this trial if you:

  1. Have epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has come back 6 months or more after first line chemotherapy
  2. Are due to have carboplatin chemotherapy, with or without paclitaxel (Taxol)
  3. Have satisfactory blood test results
  4. Are well enough for treatment (performance status 0 or 1)
  5. Are at least 18 years old
  6. Are willing to use reliable contraception during the trial and 6 months after the trial finishes if there is any chance that you could become pregnant

You cannot enter this trial if you:

  1. Have a rare type of cancer such as ‘mixed Mullerian cancer’, non epithelial ovarian cancer or mucinous cancer of the peritonem
  2. Have cancer that has spread to the brain (brain metastases), or are known to have a tumour pressing on your spine
  3. Have already had more than one course of chemotherapy in the past
  4. Have high blood pressure that is higher than 150/100, despite treatment
  5. Have had another cancer in the past 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated
  6. Have had radiotherapy in the last 3 weeks
  7. Have had any experimental treatment as part of a clinical trial in the last 6 weeks
  8. Are allergic to cediranib or similar types of drugs
  9. Have had a stroke or heart attack in the last 12 months
  10. Have angina or any other serious heart problem
  11. Have had any significant bleeding problem in the last 3 months
  12. Have had major surgery in the last 2 weeks
  13. Are still having severe side effects (apart from hair loss and numbness and tingling in hands and feet) from other cancer treatment
  14. Have any other serious medical condition that means you cannot have the treatment in this trial

Trial design

This is a phase 3 trial. It will recruit about 2,000 women into 3 groups. It is a randomised trial. The women taking part are put into 3 different treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial.

If you are in group 1, you will have standard treatment and a dummy drug (placebo). And then you will continue to take the placebo alone.

If you are in group 2, you will have standard treatment and cediranib. When you finish chemotherapy, you will stop taking cediranib and start taking the placebo.

If you are in group 3, you will have standard treatment and cediranib. And then you will continue to take cediranib alone.

Everybody will have cediranib or dummy drug (placebo) as a tablet once a day for up to 18 months, or longer if you and your doctor think you are getting benefit from the trial drug.

The standard chemotherapy for ovarian cancer is either paclitaxel and carboplatin or carboplatin alone. However there are other types of chemotherapy that might suit you better such as gemcitabine and carboplatin or cisplatin alone. Which treatment you have depends on your individual case. The doctor will explain how often you have this treatment and for how long.

This trial will recruit women in 3 stages. The first stage has finished recruiting patients. It showed that the side effects of combining cediranib with chemotherapy are acceptable. The second stage is now open and will recruit 600 women to see how well cediranib works to slow or stop cancer growth for ovarian cancer that has come back. If it works, the third stage of the trial will open and recruit about  2, 000 women. This will provide information about how well the treatment works long term. 

You will fill in a questionnaire 

  1. Before you start treatment
  2. Every 3 weeks while you are having chemotherapy
  3. Then every 6 weeks until you finish treatment 
  4. Every 3 months while you are having follow up appointments.

The questionnaire will ask you about any side effects you have and about how you have been feeling. This is called a quality of life questionnaire.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer and for extra blood samples. If you don’t want to give tissue or extra blood samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

Before you can take part in this trial, a doctor will examine you and you will have various tests. The tests include:

  1. Heart trace (ECG)
  2. Blood and urine tests
  3. Chest X-ray or CT scan of your chest
  4. CT scan or MRI scan of your stomach and lower abdomen (lower pelvic area)

You may also have an echocardiogram (heart scan).

You will go to the hospital once every 3 weeks for chemotherapy. You have treatment as an outpatient so you won’t have to stay in hospital as part of this trial.

When you finish chemotherapy, you will see the trial doctor at the hospital every 6 weeks while you are having cediranib or the placebo.

You will have a CT or MRI scan of your lower abdomen and pelvic area when you finish chemotherapy. And then one year after you start treatment and again when you finish treatment with the dummy drug or cediranib. This is to see how well the treatment has worked.

Your treatment will take up to 18 months, or longer if tests show you are benefiting from cediranib. After you finish treatment, you will go to the hospital

  1. Every 3 months in the second and third year
  2. Every 6 months in the fourth and fifth year
  3. Yearly after that

At each appointment you will have some blood tests and a physical examination.

Side effects

All treatments have side effects. Cediranib (Recentin or AZD2171) is a new treatment and there may be some side effects that the doctors don’t know about yet. In trials so far, the most common side effects have been

  1. High blood pressure
  2. Diarrhoea
  3. Feeling or being sick
  4. Muscle pain and weakness
  5. Tiredness
  6. Problems with your thyroid gland
  7. Sore mouth and dry mouth
  8. Loss of appetite and weight loss
  9. Headaches
  10. A drop in the number of white blood cells and platelets causing an increased risk of infections and bleeding problems
  11. Blood clots

Very rarely, some people may develop a small hole in the intestine while taking cediranib. But the risk of this happening is very small and your doctor will treat this side effect straightaway. Your doctor will explain this risk to you in more detail.


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