A trial looking at weekly chemotherapy for ovarian cancer (ICON 8)

Who can enter

You can enter this trial if you

• Have been diagnosed with ovarian cancer, fallopian tube cancer or primary peritoneal cancer
• Have cancer that is stage 1c, 2, 3 or 4 (if your cancer is stage 1c or 2a, it must also be either a high grade serous cancer, a clear cell cancer, or another type that is poorly differentiated – your doctor can advise you about this)
• 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 reliable contraception during the trial and for 6 months afterwards if there is any chance you could become pregnant
• Are female and at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread to your brain or spinal cord (central nervous system)
• Have a rare type of cancer called mixed Mullerian cancer, ovarian cancer that is not epithelial, certain rare types of peritoneal cancer (the trial doctor can advise you about this) or a borderline tumour
• Have already had chemotherapy, biological therapy or hormone therapy for ovarian cancer
• Have had any other cancer in the last 5 years apart from DCIS, carcinoma in situ of the cervix or non melanoma skin cancer that have been successfully treated, or cancer of the womb lining that was stage 1A and low grade
• Have ever had radiotherapy to your tummy (abdomen) or the area between your hip bones (pelvis)
• Are going to have chemotherapy directly into your abdomen (intraperitoneal chemotherapy)
• Have damage to your nerves (peripheral neuropathy)
• Are having any other experimental drug
• Are known to be sensitive to carboplatin or paclitaxel, or their ingredients
• Have any other medical condition that the trial doctors think could affect your taking part
• Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit about 1,500 women. It is a randomised trial. The people 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.

• Women in group 1 have standard treatment which is carboplatin and paclitaxel once every 3 weeks
• Women in group 2 have carboplatin once every 3 weeks and a lower dose of paclitaxel once a week
• Women in group 3 have lower doses of both carboplatin and paclitaxel once a week

You have carboplatin and paclitaxel through a drip into a vein. The exact length of time it takes to have the drugs depends on which treatment group you are in.

You may have surgery followed by 6 cycles of chemotherapy. Or you may have 3 cycles of chemotherapy followed by surgery, then 3 more cycles of chemotherapy. But everybody will have chemotherapy for a total of 18 weeks.

If you are in group 2 or group 3 and have your surgery after 3 cycles of treatment, you will not have any chemotherapy in the 3rd week of the 3rd treatment cycle. This gives you a bit longer to recover before your surgery which you have a couple of weeks later.

Everybody will be asked to fill out a questionnaire before starting treatment, at the beginning of each cycle of chemotherapy and at follow up appointments after you finish treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The trial team will ask your permission to take some blood samples during the trial, and to get a sample of tissue removed when you have (or had) surgery. Researchers will use these samples to look for substances called biomarkers. These may help in the future to work out which women would benefit most from having weekly chemotherapy.

They also want to look for biomarkers that could show that a cancer is starting to grow again before it can be seen on scans. And they want to look at how genes might affect ovarian cancer and how people respond to treatment. You don’t have to give these extra samples for research if you don’t want to. You can still take part in the trial.

Hospital visits

You will see the trial doctors and have some tests before you start chemotherapy. The tests include

• Physical examination
• Chest X-ray
• Heart trace (ECG)
• CT scan or MRI scan

Women in group 1 go to hospital once every 3 weeks to have treatment. Women in the other 2 groups go every week.

You have blood tests before each chemotherapy treatment, so women in groups 2 and 3 will have 12 extra blood tests.

You have a scan after 6 cycles of treatment and the first 186 women to join the trial will be asked to have an extra scan 9 months after they were randomised to their treatment group.

After you finish treatment, you will see the trial team

• Every 6 weeks until 9 months after you joined the trial
• Then every 3 months until you have been in the trial for 2 years
• And every 6 months for 4 years after that

Side effects

The possible side effects of carboplatin and paclitaxel include

• Feeling or being sick
• Tiredness (fatigue)
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Hair loss
• Aches and pains
• Pins and needles or tingling in your hands and feet (peripheral neuropathy)
• Ringing in the ears
• Mood swings

It is possible that having chemotherapy each week may make side effects more likely or more severe. But the trial doctors don’t expect it to cause any different side effects.

Some women have an allergic reaction to paclitaxel and occasionally to carboplatin. You have drugs called steroids and antihistamines before each treatment to reduce the risk of a reaction.