Trial Summary

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

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.

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.