A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer
- Conditions
- Epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12607000188437
- Lead Sponsor
- Medical Research Council (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 1520
1. Written informed consent and able to comply with the protocol2. Histologically confirmed:a. High risk International Federation of Gynecology and Obstetrics (FIGO) stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancerb. FIGO stage IIb–IV (all grades, all histological types) epithelial ovarian cancerc. Fallopian tube or primary peritoneal cancer3. Patients fit enough to receive protocol treatment4. Urine dipstick for proteinuria <2+ (if urine dipstick is > or = 2+, 24 hour urine must demonstrate < or = 1 g of protein).
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 treatment2. 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 cancer3. Uncontrolled hypertension4. Current or recent (within 10 days of first dose of study treatment) use of aspirin >325 mg/day5. 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
- Secondary Outcome Measures
Name Time Method