AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin
added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian,
fallopian tube or primary peritoneal cancer with disease progression within 6 months of
platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or
topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive
Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on
study treatment is until disease progression. Patients will then receive standard of care,
those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target
sample size is 100-500 individuals.