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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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ICON7
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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
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Topic
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Cancer
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Portfolio Eligibility
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UKCRN adopted, non-commercial study
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ISRCTN
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91273375
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EudraCT
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2005-003929-22
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MREC N° |
Ethics approval rece
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UKCRN ID |
1763
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WHO ID
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Research Summary
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To evaluate the efficacy and safety of adding bevacizumab to carboplatin and paclitaxel in patients with epithelial ovarian cancer.
Information on this trial can also be found at the MRC CTU website: http://www.ctu.mrc.ac.uk/studies/ICON7.asp
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Fallopian Tubes
Ovary
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Phase |
III
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Current Status
| Closed - in follow-up |
| Closure Date | 17/02/2009 |
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Sample Size
| 1520 |
| Accrual to Date |
 24% |
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Geographical Scope
| International Multi-Centre |
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Lead Country
| England (also active in Scotland) |
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Main Inclusion Criteria
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•Written informed consent and able to comply with the protocol
•Histologically confirmed:
-high risk FIGO stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancer
-FIGO stage IIb – IV (all grades, all histological types) epithelial ovarian cancer
-fallopian tube or primary peritoneal cancer
•Patients fit enough to receive protocol treatment
•Urine dipstick for proteinuria < 2+ (. If urine dipstick is > or equal 2+, 24 hour urine must demonstrate < or equal 1 g of protein)
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Main Exclusion Criteria
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Exclusion criteria:
•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
•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
•Uncontrolled hypertension
•Current or recent (within 10 days of first dose of study treatment) use of aspirin > 325 mg/day
•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)
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Chief Investigator(s)
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| Dr Timothy Perren |
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Further details, please contact
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Ms Christina Howitt
Medical Research Council
222 Euston Road
London
NW1 2DA
UNITED KINGDOM
chh@ctu.mrc.ac.uk
| Ms Cybil Kwakye
Medical Research Council
222 Euston Road
London
NW1 2DA
UNITED KINGDOM
cyk@ctu.mrc.ac.uk
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Funder(s) |
Cancer Research UK
F. Hoffmann-La Roche
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Sponsor(s) |
Medical Research Council
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