Table 2.

Phase III trials of bevacizumab

Trial	GOG-0218	ICON7	OCEANS	AURELIA
Setting/design	Primary adjuvant	Primary adjuvant	Recurrent platinum- sensitive	Recurrent platinum- resistant
	Double-blinded, placebo-controlled	Open-label	Double-blinded, placebo-controlled	Randomized physician-specified, cohort constrained (see text)
	Three-arm study	Two-arm study	Two-arm study	Two-arm study
	Bev for 15 months	Bev for 12 months	Bev/placebo until PD or unacceptable toxicity	Bev until PD or unacceptable toxicity
Bev dosage	15 mg/kg/q3w	7.5 mg/kg/q3w	15mg/kg/q3w	10mg/kg/q2w or 15mg/kg/q3w (schedule depended on chemotherapy partner)
Treatment	Combination with CBDCA and PAC	Combination with CBDCA and PAC	Combination with CBDCA and GEM	Combination with PLD, TOP or weekly PAC
Treatment cycle (days)	21	21	21	21 or 28
Patient populations	Stage III (suboptimal) Stage III (optimal, visual/palpable) Stage IV	Stage I or IIA (grade 3/clear cell histology) Stages IIB–IV (all)	Measurable platinum- sensitive recurrent disease	Measurable and assessable (GCIG) Platinum-resistant recurrent disease
Primary Endpoint	PFS	PFS	PFS	PFS
Additional endpoint	OS analysis (formal testing at time of PFS)	Defined final OS analysis (pending)	ORR, OS and DOR	ORR, OS safety and QOL
	IRC	No IRC	IRC	No IRC

Bev, bevacizumab; CBDCA, carboplatin; PAC, paclitaxel; GEM, gemcitabine; PLD, pegylated liposomal doxorubicin; TOP, topotecan; PFS, progression-free survival; OS, overall survival; ORR, objective response rate; DOR, duration of response; QOL, quality of life; IRC, independent radiologic review committee; GCIG, Gynecologic Cancer InterGroup