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Overview

ICON7 is a randomised (1:1 ratio), 2 arm, multi-centre, Gynecologic Cancer InterGroup (GCIG) open-label phase III trial designed to evaluate the safety and efficacy of adding bevacizumab, to standard chemotherapy (carboplatin and paclitaxel), in patients with advanced epithelial ovarian or primary peritoneal cancer.

Bevacizumab (Avastin®) is a recombinant humanised anti-VEGF (anti - Vascular Endothelial Growth Factor) monoclonal antibody. It is a new type of treatment that acts by interfering with the development of tumour blood vessels.

Objectives

This is a randomised controlled phase III trial in patients with high risk early stage (FIGO stage I or IIA clear cell or Grade 3 carcinoma) or advanced stage (FIGO stage IIB or greater, all grades and all histological subtypes) epithelial ovarian carcinoma, primary peritoneal carcinoma or fallopian tube carcinoma, to evaluate the addition of bevacizumab to standard chemotherapy with carboplatin and paclitaxel.

Duration of Treatment

In the control arm, the duration of treatment is expected to be 18 weeks. In the research arm the duration of treatment is expected to be 54 weeks. Treatment delays due to toxicity may extend the treatment duration in both arms.

Recruitment

First patient in December 2006
1520 patients (estimate accrual time 18 to 24 months)

Closed to recruitment on Monday 16th February 2009, with a total of 1528 patients.


ISRCTN number: ISRCTN91273375
Sponsor: Medical Research Council
Funding Body: Roche (F. Hoffmann-La Roche Ltd.)


Chief Investigator: Dr Tim Perren
Co-Lead CI: Dr Amit M Oza