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 | https://doi.org/10.1186/ISRCTN91273375 |
| EudraCT/CTIS number | 2005-003929-22 |
| ClinicalTrials.gov number | NCT00483782 |
| Secondary identifying numbers | ACTRN12607000188437 |
- Submission date
- 29/11/2005
- Registration date
- 25/01/2006
- Last edited
- 05/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Tim Perren
Scientific
Scientific
CRUK Clinical Centre in Leeds
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 206 4670 |
|---|---|
| t.j.perren@leeds.ac.uk |
Study information
| Study design | Randomised (1:1 basis) two-arm multicentre open-label phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found on the website at http://www.icon7trial.org |
| Scientific 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 |
| Study acronym | ICON7 |
| Study hypothesis | To evaluate the efficacy and safety of adding bevacizumab to carboplatin and paclitaxel in patients with epithelial ovarian cancer. |
| Ethics approval(s) | London MREC, 14/09/2006 |
| Condition | Epithelial ovarian cancer |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bevacizumab, carboplatin, paclitaxel |
| Primary outcome measure | Progression-free survival (PFS) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2006 |
| Overall study end date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,520 |
| Participant 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) |
| Participant 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) |
| Recruitment start date | 01/10/2006 |
| Recruitment end date | 31/10/2008 |
Locations
Countries of recruitment
- Australia
- Canada
- Denmark
- England
- Finland
- France
- Germany
- New Zealand
- Norway
- Sweden
- United Kingdom
Study participating centre
CRUK Clinical Centre in Leeds
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Medical Research Council (UK)
Research council
Research council
222 Euston Road
London
NW1 2DA
United Kingdom
| Website | http://www.ctu.mrc.ac.uk |
|---|---|
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Industry
F. Hoffman-La Roche
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 29/12/2011 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | cost-effectiveness results | 01/06/2016 | Yes | No | |
| Results article | exploratory outcome results | 01/01/2019 | 05/02/2019 | Yes | No |
Editorial Notes
05/02/2019: Publication reference added
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
18/05/2017: Publication reference added.
