GCIG trials for rare ovarian histologies Edward L. Trimble, MD, MPH National Cancer Institute, USA

Open trials Japanese Gynecologic Oncology Group 3017 Carboplatin/ paclitaxel versus carboplatin/ irinotecan Accrual to date: 345/planned accrual: 650 Groups: JGOG, KGOG active; pending NCRN/MRC, GINECO, MITO

Approved concepts NCRN mEOC/GOG 241 trial for mucinous ovarian cancer – Carboplatin/paclitaxel vs oxaliplatin/capecitabine, +/- bevacizumab; sample size: N=332 – Other GCIG groups: AGO

mEOC/ GOG 241: A GCIG Intergroup multicentre phase III trial of open label carboplatin and paclitaxel +/- bevacizumab compared with oxaliplatin and capecitabine +/- bevacizumab as first line chemotherapy in patients with mucinous epithelial ovarian cancer Newly Diagnosed Stage II-IV or Recurrent Stage I Mucinous Ovarian Carcinoma Paclitaxel 175 mg/m2 Carboplatin AUC 6 Q. 21d X 6 Paclitaxel 175 mg/ m2 Carboplatin AUC 6 Bevacizumab 15 mg/kg Q. 21d X 6 Capecitabine 850 mg/m2 bd Oxaliplatin 130 mg/m2 Q. 21d X 6 Capecitabine 850 mg/m2 bd Oxaliplatin 130 mg/m2 Bevacizumab 15 mg/kg Q. 21d X 6 Bevacizumab 15 mg/kg Q. 21d X 12 Bevacizumab 15 mg/kg Q. 21d X 12 Randomize 322 pts.

Approved concepts GOG RTM 0602 Chemo-naive primary or recurrent sex cord/ stromal tumors of the ovary; Randomized phase II Carboplatin/paclitaxel vs BEP Sample size: N= patients

Phase II trials – GOG 187: ovarian stromal tumors – Paclitaxel, activated Nov 2000; accrual 25/37 GOG 0239: recurrent low-grade serous ovarian cancer – AZD 6244 (MEK ihhibitor), fast accrual to 1 st stage; 27 pts/9 mos; 2 nd stage opened May 2009; N=50 GOG 0251: sex cord stromal cancer – Bevacizumab, activated Sept 2008

Phase II trials GOG 0254: sunitinib in persistent or recurrent clear cell cancer, activation pending; N=65 in two stages GOG RTM 0907: upfront clear cell ovarian cancer; carboplatin/paclitaxel + sunitinib; protocol in design