A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer

Phase 3

Completed

• Conditions: Epithelial ovarian cancer; Cancer; Ovarian cancer

• Registration Number: ISRCTN91273375
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

1. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22204725 2. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26115797 3. 2016 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/27325335 4. 2019 exploratory outcome results in: https://www.ncbi.nlm.nih.gov/pubmed/30449719 (added 05/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-25
• Study Completion: 2008-10-31
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1520

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)

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall survival (OS)<br> 2. Response rate<br> 3. Duration of response<br> 4. Toxicity<br> 5. Quality of life (QoL)<br> 6. Health economics<br> 7. Translational (biomarker) research<br>