Condition category
Cancer
Date applied
29/11/2005
Date assigned
25/01/2006
Last edited
29/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Tim Perren

ORCID ID

Contact details

CRUK Clinical Centre in Leeds
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 206 4670
t.j.perren@leeds.ac.uk

Additional identifiers

EudraCT number

2005-003929-22

ClinicalTrials.gov number

NCT00483782

Protocol/serial number

ACTRN12607000188437

Study information

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

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

London MREC on 14/09/2006

Study design

Randomised (1:1 basis) two-arm multicentre open-label phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found on the website at http://www.icon7trial.org

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

Phase

Phase III

Drug names

Bevacizumab, carboplatin, paclitaxel

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,520

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, Finland, France, Germany, New Zealand, Norway, Sweden, United Kingdom

Trial participating centre

CRUK Clinical Centre in Leeds
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor type

Research council

Website

http://www.ctu.mrc.ac.uk

Funders

Funder type

Industry

Funder name

F. Hoffman-La Roche

Alternative name(s)

Hoffman-La Roche, F. Hoffmann-La Roche Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22204725
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26115797

Publication citations

  1. Results

    Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stähle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM, , A phase 3 trial of bevacizumab in ovarian cancer., N. Engl. J. Med., 2011, 365, 26, 2484-2496, doi: 10.1056/NEJMoa1103799.

  2. Results

    Oza AM, Cook AD, Pfisterer J, Embleton A, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Park-Simon TW, Rustin G, Joly F, Mirza MR, Plante M, Quinn M, Poveda A, Jayson GC, Stark D, Swart AM, Farrelly L, Kaplan R, Parmar MK, Perren TJ; ICON7 trial investigators, Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial, Lancet Oncol, 2015, doi: 10.1016/S1470-2045(15)00086-8.

Additional files

Editorial Notes