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. Author manuscript; available in PMC: 2014 Feb 1.
Published in final edited form as: Expert Opin Biol Ther. 2012 Nov 29;13(2):283–294. doi: 10.1517/14712598.2012.745508

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