A trial of chemotherapy with or without bevacizumab for ovarian cancer, primary peritoneal cancer or fallopian tube cancer (ICON 7)

This trial is looking at chemotherapy combined with monoclonal antibody therapy as first line treatment for ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

Doctors usually treat ovarian cancer with surgery and chemotherapy. They commonly use the chemotherapy drugs carboplatin and paclitaxel (Taxol).

Bevacizumab (Avastin) is a type of biological therapy called a monoclonal antibody. Researchers think that giving bevacizumab as well as chemotherapy may be better than chemotherapy alone. But they are not sure yet. All treatments have side effects, and it important that people don’t have treatment they don’t need.

The aim of this trial is to find out if adding Avastin to chemotherapy helps stop ovarian cancer coming back after surgery.

Please note this trial is no longer recruiting patients.

Recruitment

Start 13/12/2006

End 16/02/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
Have cancer that is stage 1 and grade 3, or stage 2, 3 or 4 and any grade, or clear cell cancer at any stage
Have had surgery to remove as much of your cancer as possible in the last 8 weeks (unless you have stage 4 cancer and surgery was not possible)
Are well enough for treatment (performance status 0, 1 or 2)
Have satisfactory blood and urine test results
Are at least 18 years old

You cannot enter this trial if you

Have a rare type of cancer called ‘mixed Mullerian cancer’, or non epithelial ovarian cancer such as germ cell tumour
Have a borderline ovarian tumour
Have cancer that has spread to your brain, or have spinal cord compression
Have already had chemotherapy, biological therapy or hormone therapy for ovarian cancer
Are due to have another operation in the next 13 months (58 weeks)
Have had radiotherapy to your pelvic area in the past
Have high blood pressure that remains above 150/100 despite medication
Have angina or any other serious heart problem
Have had a stroke, a heart attack or a brain haemorrhage in the last 6 months
Have a wound, ulcer or bone fracture that hasn’t healed yet
Have any other serious medical condition
Have had experimental treatment as part of another trial in the last month
Have taken high dose aspirin or drugs to thin your blood (anti coagulants) in the 10 days before you are due to start treatment
Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 1,520 women into two groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group A you will have carboplatin and paclitaxel. You have both drugs through a drip into a vein once every 3 weeks. Each 3 weeks of treatment is one cycle. You will have 6 cycles over 18 weeks (about 4 months).

If you are in group B, first you will have carboplatin, paclitaxel and bevacizumab through a drip into a vein once every 3 weeks. Each 3 weeks of treatment is one cycle. You will have 6 cycles over 18 weeks (about 4 months). After that you have bevacizumab alone once every 3 weeks for another 12 cycles (nearly 9 months). So you have treatment for over a year altogether.

You will fill out a questionnaire before you start treatment, after each of the first 6 cycles of treatment, and after every other cycle after that (if you are in group B). It will ask you how you have been feeling and about any side effects you have had. It is called a quality of life questionnaire.

Hospital visits

You will see the doctors and have some tests before you start treatment as part of this trial. The tests include

Physical examination
Heart trace (ECG)
Blood tests, including a CA125 test
Urine tests
CT scan of your stomach and groin area
Chest X-ray or chest CT scan

You will go to the out patients department to have treatment once every 3 weeks. You will have blood tests and a physical examination at each visit.

You will see the doctors and have a scan after cycle 3 and cycle 6, and then every 6 months for 2 years. How often you have a scan after that will depend on your individual situation.

Side effects

The most common side effects of carboplatin and paclitaxel are

Feeling or being sick
A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Hair loss
Numbness and tingling in hands and feet (peripheral neuropathy)
Sore mouth
Diarrhoea
Aching muscles or joints

The most common side effects of bevacizumab (Avastin) are