ICON8B Trial summary

 Recruitment into the ICON8B trial took place between 06/06/2011 and 08/05/2020.

 

ICON8B is an international trial of weekly chemotherapy and bevacizumab for women with ovarian cancer, fallopian tube cancer or primary peritoneal cancer.*

• In this study we are investigating the way in which we give chemotherapy to women with ovarian cancer.
• Ovarian cancer is normally treated with surgery and chemotherapy. Surgery aims to remove as much cancer as possible. Chemotherapy destroys or stops the growth of the cancer cells and is normally given every 3 weeks over 18 weeks.
• Women in the study will receive a drug called bevacizumab which is given with chemotherapy and continued for one year after chemotherapy.

Recent studies in ovarian cancer treatment have suggested the following:

1. Giving weekly chemotherapy rather than giving chemotherapy every 3 weeks may give better results.
2. Giving bevacizumab (also known as Avastin) with 3 weekly chemotherapy may give better results than giving 3 weekly chemotherapy alone.

The ICON8B trial aims to improve treatment outcomes for women with advanced ovarian cancer by comparing these two different treatment approaches.

*Epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer are three types of cancer that affect women. The term “ovarian cancer” is often used to refer to all of them.   These cancers are all treated in the same way, which means that women with any of the three can be included in this study.

Women who consent to take part in the ICON8B trial will be allocated to 1 of the following 2 treatment groups:

Group B1

Women in this group will receive 18 weeks of:

• Carboplatin once every 3 weeks
• Paclitaxel once every 3 weeks
• Bevacizumab once every 3 weeks followed by bevacizumab continuing alone for approximately 11 months

Group B3

Women in this group will receive 18 weeks of:

• Carboplatin once every 3 weeks
• Paclitaxel once every week (on days 1, 8 and 15 of a 3-weekly cycle)
• Bevacizumab once every 3 weeks followed by bevacizumab continuing alone for approximately 11 months

Aims of the Study

In this study we aim to find out the answers to the following questions:

• Is one treatment approach better than the other?
• Which treatment causes less side effects?
• Which treatment offers better quality of life?
• Is it safe to use bevacizumab to treat women who are having surgery at the same time as chemotherapy?

Eligibility

To participate in ICON8B patients must have met all the following criteria:

• Are female and at least 18 years old
• Have been diagnosed with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
• Have a cancer that is staged as high risk
• Are well enough to be up and about for at least half the day
• 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

To participate in ICON8B patients must not have met all the following criteria:

• Have cancer that has spread to your brain or spinal cord
• Have a rare type of cancer called mixed Müllerian cancer, ovarian cancer that is not epithelial, certain rare types of peritoneal cancer, 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 ductal carcinoma in-situ (DCIS) of the breast, carcinoma in-situ of the cervix or non-melanoma skin cancer that have been successfully treated, or endometrial cancer (a cancer of the womb lining) that was stage IA and low grade
• Have ever had radiotherapy to your abdomen or 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, these include but are not limited to:
• Uncontrolled hypertension
• Cardiovascular disease
• Inflammatory bowel disease
• Active ulcer or bone fracture
• Are anticipated to require extensive dental work during treatment
• Are pregnant or breastfeeding

Treatment on trial

If you agree to take part in this study, you will be allocated to one of the two treatments by a computer. This is a process called randomisation. This means that neither you nor your doctor will be able to decide which treatment you will have. Trials are often randomised because if the researchers or doctors were to decide who should get which treatment, they might be influenced by what they know about their patients. Having randomisation allows us to be sure that results are reliable and that a fair comparison between the treatment groups can be carried out.

There is an equal chance of you receiving any of the 2 treatments. This allows us to observe any differences between the 2 groups, and when enough people have been treated we will be able to tell if there are any true differences between the treatments.

If you take part in the study you will receive treatment with bevacizumab in both arms.

Before your treatment begins you will be asked for information about your medical history and you will be examined by your doctor.

Before you start treatment you will have a:

• Chest X-ray
• Heart trace (known as an electrocardiogram)
• CT scan or MRI scan

These tests will enable your medical team to check that it is safe for you to take part in this study.

All the treatments will be given, one at a time, through a drip inserted into a vein, usually on the back of your hand or forearm. The frequency and length of each dose of treatment varies between the treatment groups but you can expect to be in hospital for half a day to a whole day to receive treatment. No overnight stays are planned for giving treatment in this trial.

 

If you are entering the trial after having had surgery, the diagram below shows a plan of the treatment you could receive on trial and the length of treatment.

 

 

 

If you are entering the trial before having surgery, the diagram below shows a plan of the treatment you could receive on trial and the length of treatment.

 

 

Side Effects

Common side-effects of carboplatin and paclitaxel (more than 10% of patients)

• Nausea
• A reduction in white blood cells (neutropenia) which will make you more prone to infection
• Low platelet count: Chemotherapy can also reduce the number of platelets in your blood. This can lead to an increased risk of bruising and bleeding.
• Tiredness
• Hair loss
• Aches and pains
• Pins and needles or tingling in the hands and feet.
• Ringing in the ears
• Mood swings
• Allergic reactions. Some women have an allergic reaction to either carboplatin or paclitaxel. Before each treatment you will be given steroids and antihistamines to reduce the risk of a reaction.

Common side-effects of bevacizumab (more than 10% of patients)

• Raised blood pressure
• Protein in the urine: you are unlikely to notice this, so your research nurse will test your urine before every treatment. If you are receiving bevacizumab you may be asked to collect your urine for 24 hours before your next treatment so we can measure how much protein is being passed.
• Poor wound healing: This is why it is important that you have an adequate break between surgery and treatment with bevacizumab. Please inform us if you have any wounds or ulcers that are not healing.

Less common side-effects of bevacizumab (less than 10% of patients)

• Increased risk of bruising or bleeding
• Bowel perforations (development of a hole in the bowel
• Increased risk of blood clots
• Chest pains or chest tightness
• Allergic reaction to bevacizumab (very rare): such as fever, chills, headache, tiredness, aching muscles and joints, itching, redness of skin, nausea breathlessness, wheeziness and mild drop in blood pressure when the bevacizumab injection is being given. Most of these disappear upon temporary slowing or stopping of the treatment or after the administration of paracetamol and/or anti-allergic medication. Osteonecrosis of the jaw

For further information on the ICON8B trial please speak to your GP or hospital team in the first instance.