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GCIG trials for rare ovarian histologies

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

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GCIG trials for rare ovarian histologies

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

  2. 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

  3. 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

  4. 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 Randomize 322 pts. 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

  5. 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=80-128 patients

  6. 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 1st stage; 27 pts/9 mos; 2nd stage opened May 2009; N=50 • GOG 0251: sex cord stromal cancer • Bevacizumab, activated Sept 2008

  7. 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

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