A trial comparing two combinations of chemotherapy for clear cell ovarian cancer (CCC1)

Who can enter

You can enter this trial if you

• Have recently been diagnosed with stage 1 to 4 clear cell ovarian cancer
• Are due to have, or have recently had surgery to remove your cancer (you’ll need to start treatment on the trial within 6 weeks of your operation)
• Have satisfactory blood test results
• Are up and about and well enough to look after yourself (performance status 0 or 1)
• Are at least 18 years old

You cannot enter this trial if you

• Have borderline ovarian cancer
• Have already had chemotherapy or radiotherapy to treat your ovarian cancer
• Have had chemotherapy in the past, unless it was for early stage breast cancer at least 5 years ago
• Have had radiotherapy in the past, unless it was for early stage breast cancer, skin cancer or head and neck cancer at least 5 years ago
• Are being treated with an anti viral drug called Atazanavir
• Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or womb, or non melanoma skin cancer
• Have a very large amount of fluid (acsites) on your abdomen
• Have a bowel obstruction, severe diarrhoea or bleeding from your stomach or bowel
• Have heart problems such as angina, or have had a heart attack in the last 6 months
• Have any other serious infection or medical condition
• Know you are allergic to castor oil or any of the drugs used in this trial
• Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit over 650 patients into 2 groups. 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.

Group 1 will have paclitaxel and carboplatin. You have both of these drugs once every 3 weeks, though a drip into a vein. Each 3 week period is called a cycle of treatment. You will have 6 cycles of treatment over 18 weeks.

Group 2 will have irinotecan and cisplatin. You have both these drugs through a drip into a vein. You have cisplatin once every 4 weeks. Each 4 week period is one cycle of treatment. You have irinotecan once a week for 3 weeks out of every 4. You will have 6 cycles of treatment over 24 weeks.

Hospital visits

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

• Physical examination
• Blood pressure and pulse
• Blood tests
• Chest X-ray
• Heart trace (ECG)
• CT scan or MRI scan

You will go to the hospital for treatment once every 3 weeks if you are in Group 1. And once a week for 3 weeks out of every 4 if you are in Group 2.

You will have blood tests before each cycle of treatment. And a chest X-ray and CT or MRI scan after 3 cycles and 6 cycles.

After you finish treatment you will see the doctors and have blood tests

• Every 3 months for 2 years
• Every 6 months for the next 2 years
• Once a year after that

Side effects

All of the chemotherapy drugs in this trial are already used to treat cancer. They all have some side effects.

The most common side effects of paclitaxel and carboplatin are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and shortness of breath
• Muscle ache and joint pain
• Feeling or being sick
• Hair loss
• Pins and needles in hands and feet (peripheral neuropathy)
• Mild allergic reaction

The most common side effects of irinotecan and cisplatin are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and shortness of breath
• Diarrhoea
• Hair loss
• Feeling or being sick
• Loss of kidney function (you will have lots of fluid through a drip with the cisplatin to help stop this happening)

There is more information about the side effects of paclitaxel (Taxol), carboplatin, irinotecan and cisplatin on CancerHelp UK.