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A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer
ISRCTN ISRCTN91273375
DOI 10.1186/ISRCTN91273375
ClinicalTrials.gov identifier NCT00483782
EudraCT number 2005-003929-22
Public title A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer
Scientific title
Acronym ICON7
Serial number at source ACTRN12607000188437
Study hypothesis To evaluate the efficacy and safety of adding bevacizumab to carboplatin and paclitaxel in patients with epithelial ovarian cancer.
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=112
Ethics approval London MREC on 14/09/2006
Study design Randomised (1:1 basis), two-arm, multicentre, open-label phase III study
Countries of recruitment Australia, Canada, Denmark, Finland, France, Germany, New Zealand, Norway, Sweden, United Kingdom
Disease/condition/study domain Epithelial ovarian cancer
Participants - inclusion criteria 1. Written informed consent and able to comply with the protocol
2. Histologically confirmed:
2.1. High risk International Federation of Gynaecology and Obstetrics (FIGO) stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancer
2.2. FIGO stage IIb - IV (all grades, all histological types) epithelial ovarian cancer
2.3. Fallopian tube or primary peritoneal cancer
3. Patients fit enough to receive protocol treatment
4. Urine dipstick for proteinuria less than 2+ (if urine dipstick is greater than or equal to 2+, 24 hour urine must demonstrate less than or equal to 1 g of protein)
Participants - exclusion criteria 1. Surgery (including open biopsy), or radiotherapy within the last 4 weeks prior to first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment
2. Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer
3. Uncontrolled hypertension
4. Current or recent (within 10 days of first dose of study treatment) use of aspirin greater than 325 mg/day
5. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes (except for line patency)
Anticipated start date 01/10/2006
Anticipated end date 31/10/2008
Status of trial Completed
Patient information material Patient information can be found on the website at http://www.icon7trial.org
Target number of participants 1,520
Interventions Control arm: carboplatin plus paclitaxel on day 1 every 3 weeks until disease progression or for a maximum of 6 cycles
Research arm: carboplatin plus paclitaxel on day 1 every 3 weeks until disease progression or for a maximum of 6 cycles, with bevacizumab on day 1 every 3 weeks until disease progression or for a maximum of 18 cycles
Primary outcome measure(s) Progression free survival (PFS)
Secondary outcome measure(s) 1. Overall survival (OS)
2. Response rate
3. Duration of response
4. Toxicity
5. Quality of life (QoL)
6. Health economics
7. Translational (biomarker) research
Sources of funding F. Hoffmann-La Roche (Switzerland)
Trial website http://www.icon7trial.org
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22204725
Contact name Dr  Tim  Perren
  Address CRUK Clinical Centre in Leeds
St Jamesís University Hospital
Beckett Street
  City/town Leeds
  Zip/Postcode LS9 7TF
  Country United Kingdom
  Tel +44 (0)113 206 4670
  Fax +44 (0)113 242 9886
  Email t.j.perren@leeds.ac.uk
Sponsor Medical Research Council (UK)
  Address 222 Euston Rd
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
  Sponsor website: http://www.ctu.mrc.ac.uk
Date applied 29/11/2005
Last edited 20/09/2012
Date ISRCTN assigned 25/01/2006
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