Key information

Recruitment dates:

1 July, 2015 to 1 July, 2019
(Trial recruitment closed)

Trial phase:

phase III

Treatment stage:

primary treatment

Trial investigator:

Dr Andrew Clamp

Ms Emma Kent - e.kent@ucl.ac.uk

Trial website:

Tags:

chemotherapy
bevacizumab
Avastin
advanced ovarian cancer
carboplatin
paclitaxel

Acronym:

ICON8B

Clinical trial locations

Location list

Address:
Aberdeen
Address:
Airedale
Address:
Barnstaple
Address:
Bath
Address:
Bebington
Address:
Bedford
Address:
Birmingham
Address:
Blackburn
Address:
Boston
Address:
Bradford
Address:
Brighton
Address:
Bristol
Address:
Burton on Trent
Address:
Cambridge
Address:
Carlisle
Address:
Chelmsford
Address:
Cheltenham
Address:
Cottingham
Address:
Coventry
Address:
Derby
Address:
Dublin
Address:
Dundee
Address:
Exeter
Address:
Glasgow
Address:
Gloucester
Address:
Grimsby
Address:
Hertford
Address:
Guildford
Address:
Huntingdon
Address:
Ipswich
Address:
Kings Lynn
Address:
Lancaster
Address:
Leeds
Address:
Leicester
Address:
Lincoln
Address:
London
Address:
Maidstone
Address:
Manchester
Address:
Margate
Address:
Middlesbrough
Address:
Newcastle-Upon-Tyne
Address:
Northampton
Address:
Norwich
Address:
Nottingham
Address:
Northwood
Address:
Oxford
Address:
Peterborough
Address:
Portsmouth
Address:
Preston
Address:
Reading
Address:
Romford
Address:
Scunthorpe
Address:
Sheffield
Address:
Shrewsbury
Address:
Somerset
Address:
Southampton
Address:
Southend-on-Sea
Address:
Stafford
Address:
Stevenage
Address:
Stoke on Trent
Address:
Sutton
Address:
Swindon
Address:
Taunton
Address:
Torquay
Address:
Truro
Address:
Warwick
Address:
Wolverhampton
Address:
Worthing
Address:
Yeovil
Address:
York
Address:
Poole Hospital
BH15 2JB

Please note that recruitment for this trial is now closed.

Introduction

This is an international trial of weekly or three chemotherapy and bevacizumab (Avastin) for women with ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

Recent studies in ovarian cancer treatment have suggested that:

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

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

About the trial

Women will be randomised into two groups:                  

Group B1

Women in this group will receive 18 weeks of:

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

Group B3

Women in this group will receive 18 weeks of:

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

 

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

  • Is one of these treatment approaches better than the other?
  • Which treatment causes fewer 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?

 

Who can take part?

Women may be able to participate if they: 

  • Have 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 six months afterwards if there is any chance you could become pregnant

Exclusion criteria

You will not be able to participate in this trial if you:

  • 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:
  1. Uncontrolled hypertension
  2. Cardiovascular disease
  3. Inflammatory bowel disease
  4. ​Active ulcer or bone fracture
  5. Are anticipated to require extensive dental work during treatment

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.