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
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 to assess progression-free survival benefits
Medical Research Council (UK)
1,520 participants
Dec 18, 2006
Interventional
Conditions
Summary
The primary purpose of the ICON 7 study is to evaluate the safety and efficacy of adding bevacizumab, a humanised monoclonal antibody against Vascular Endothelial Growth Factor (VEGF), to standard chemotherapy with carboplatin and paclitaxel for patients with ovarian cancer.
Eligibility
Inclusion Criteria1
- 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).
Exclusion Criteria1
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Research Arm: Carboplatin (Intravenously, AUC 6) plus paclitaxel (Intravenously, 175mg/m2) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 6 cycles, with bevacizumab (intravenously, 7.5mg/kg) on day 1 every 3 weeks (one cycle) until disease progression or for a maximum of 18 cycles
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12607000188437