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UPDATE ON GCIG TRIALS FOR EPITHELIAL OVARIAN CANCER Christian Marth

UPDATE ON GCIG TRIALS FOR EPITHELIAL OVARIAN CANCER Christian Marth. Closed Trials. EORTC 55971. Upfront Surgery vs Neoadjuvant Chemotherapy Patients closed / 550 Leading EORTC Participating NCIC CTG Presentated at IGCS 2008. Tarceva Trial EORTC 55041.

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UPDATE ON GCIG TRIALS FOR EPITHELIAL OVARIAN CANCER Christian Marth

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  1. UPDATE ON GCIG TRIALS FOR EPITHELIAL OVARIAN CANCER Christian Marth

  2. Closed Trials

  3. EORTC 55971 Upfront Surgery vs Neoadjuvant Chemotherapy Patients closed / 550 Leading EORTC Participating NCIC CTG Presentated at IGCS 2008

  4. Tarceva Trial EORTC 55041 Tarceva consolidation 2 years Primary Chemotherapy Control Patients closed / 835 Leading EORTC Participating AGO-AUSTRIA, ANZGOG, GINECO, MRC/NCIC, MANGO

  5. ICON-7 TC ± BEVACIZUMAB Patients closed / 1520 Leading MRC/NCRI Participating NCIC CTG, AGO OVAR, GINECO, GEICO EORTC, ANZGOG, NSGO

  6. GOG 218 CT vs CT + Bevacizumab Placebo vs CT + Bevacizumab concurrent and extended Patients closed / 1800 Leading GOG Participating ECOG, NCCTG, NSABP, SWOG

  7. Phase III Trial of Bevacizumab in the Primary Treatment of Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer: A Gynecologic Oncology Group (GOG) Study R.A. Burger,1 M.F. Brady,2 M.A. Bookman,3J.L. Walker,4 H.D. Homesley,5 J. Fowler,6B.J. Monk,7 B.E. Greer,8 M. Boente,9 S.X. Liang10 1Fox Chase Cancer Center, Philadelphia, PA; 2Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; 3University of Arizona Cancer Center, Tucson, AZ; 4University of Oklahoma Health Sciences Center, Oklahoma City, OK; 5Brody School of Medicine, Greenville, NC; 6James Cancer Hospital at the Ohio State University, Hilliard, OH; 7University of California, Irvine Medical Center, Orange, CA; 8Seattle Cancer Care Alliance, Seattle, WA; 9Minnesota Oncology and Hematology, Minneapolis, MN; 10State University of New York at Stony Brook, Stony Brook, NY, USA

  8. GOG-0218: Investigator-Assessed PFS + BEV → BEV maintenance (Arm III) *p-value boundary = 0.0116 11 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 Proportion surviving progression free CP (Arm I) + BEV (Arm II) 0 12 24 36 Months since randomization

  9. GOG0252: IP Therapy • Epithelial Ovarian, Fallopian, or Primary Peritoneal Cancer • Optimal and Suboptimal Disease (through April 2011) • Primary Endpoint: PFS Carboplatin AUC=6 (IV) Paclitaxel 80 mg/m2 IV (d1,8,15) Bevacizumab (C2-6) Bevacizumab q21d x 16 I Carboplatin AUC=6 (IP) Paclitaxel 80 mg/m2 (d1,8,15) Bevacizumab (C2-6) Bevacizumab q21d x 16 II Cisplatin 75 mg/m2 (IP) Paclitaxel 135 mg/m2 (d1, 3h) Paclitaxel 60 mg/m2 (d8, IP) Bevacizumab (C2-6) Bevacizumab q21d x 16 III Open: 27-Jun-09 Closed: (ongoing) Target Accrual: 1250 pts Walker J. for GOG, pending

  10. GOG0262: Dose-Dense Integration • Epithelial Ovarian, Fallopian, or Primary Peritoneal Cancer • Suboptimal residual disease • Primary Endpoint: PFS Carboplatin AUC=6 Paclitaxel 80 mg/m2 (d1,8,15) +/- Bevacizumab (C2-6)$ Bevacizumab q21d$ I Carboplatin AUC=6 Paclitaxel 175 mg/m2 (d1) +/- Bevacizumab (C2-6) $ Bevacizumab q21d$ II $ Use of Bevacizumab to be determined by patient and physician choice prior to randomization Open: 27-SEP-10 Closed: --- Target Accrual: 1100 pts Chan J. for GOG, pending

  11. OCEANS: CG +/- Bevacizumab • Recurrent epithelial Ovarian, Fallopian, or Primary Peritoneal Cancer • Platinum-Free Interval stratified 6-12 vs >12 months • Industry-sponsored multicenter phase II amended to phase III • Primary Endpoint: PFS with RECIST • Secondary Endpoints: OS, GI perforation event rate Placebo q21d (until PD) Gemcitabine 1000 mg/m2 d1,8 Carboplatin AUC=4.0 d1 Placebo IV d1 I x 6 Bevacizumab q21d (until PD) Gemcitabine 1000 mg/m2 d1,8 Carboplatin AUC=4.0 d1 Bevacizumab 15 mg/kg IV d1 II x 6 Open: Apr-07 Closed: Jan-10 Target Accrual: 483 pts Aghajanian C, et al. (under analysis)

  12. GOG 0213: Secondary Cytoreduction • Epithelial Ovarian, Fallopian, or Peritoneal Cancer • One prior therapy, Platinum-free interval > 6 months • Primary Endpoint: OS Carboplatin AUC=5 Paclitaxel 175 mg/m2 (No further therapy) Maximal Secondary Cytoreduction x 6-8 A I R1 No Secondary Surgery R2 II Carboplatin AUC=5 Paclitaxel 175 mg/m2 Bevacizumab 15 mg/kg Bevacizumab 15 mg/kg (Until progression) B x 6-8 Not Surgical Candidate III Open: 06-Dec-07 Closed: Ongoing Target Accrual: 660 pts Coleman, et al. 2008

  13. GOG212: Ovarian Maintenance • Epithelial Ovarian or Primary Peritoneal Cancer • Optimal or Suboptimal Cytoreduction • Clinical CR with normal CA125, no symptoms, normal CT • Primary Carboplatin and Paclitaxel (or Docetaxel), 5-6 cycles x 12 I PG-Paclitaxel 175 mg/m2 (15 m), q28d Primary Rx: Carboplatin and Taxane (5-6 Cycles) x 12 II Paclitaxel 175 mg/m2 (3 h), q28d III Observation Open: Mar-05 Closed: --- Target Accrual: 1550 pts (3.5 Y+) Markman, et al. for GOG

  14. Calypso Published Ahead of Print on May 24, 2010

  15. AGO-OVAR-9 Carbo Paclitaxel +/- Gemcitabine Patients closed 1742 Leading AGO-OVAR Participating GINECO, NSGO,

  16. SCOTROC 4 Carbo Flat Dosing vs Intrapatient Dose Escalation Patients closed 932 Leading SGCTG Participating ANZGOG Manuscript in preparation

  17. HECTOR Carbo Topo vs Chemo (CT or CG) in recurrent Platinum-sensitive ovarian cancer Patients closed 550 Leading NOGGO/AGO-OVAR Participating AGO-AUSTRIA, GEICO

  18. AGO-OVAR-OP.2 DESKTOP II Evaluation of predictive factors for complete resection in platinum-sensitive recurrent ovarian cancer Patients closed/412 Leading AGO-OVAR Participating AGO-AUSTRIA, MITO, selected Canadian+Australian centers Report IGCS 2008, resubmitted

  19. AGO-OVAR 16 Amendment: 2 years of consolidation Pazopanib consolidation 1 yr First Line Chemotherapy Control Patients 941 / 900 Leading AGO-OVAR Participating AGOAustria, ANZGOG, BGOG, GEICO, GINECO, ICORG, JGOG, KGOG, MANGO, MITO, NSGO, US-Sites: California Consortium, NY GOG, SWOG

  20. Open/PlannedTrials

  21. AGO-OVAR-12 Carbo Paclitaxel +/- BIBF 1120 (Vargatef) Patients 525 / 1300 (2:1 random) Leading AGO-OVAR Participating AGO-Austria, BGOG, GINECO, MANGO, MITO, NSGO, US Oncology

  22. AGO – OVAR OP.3 (LION) Lymphadenectomy In Ovarian Neoplasms epithelial invasive ovarian cancer FIGO IIB - IV ECOG 0/1 and no CI against LNE no visible extra- and intra-abdominal tumor residuals no bulky lymph nodes System. Lymphadenectomy • pelvic • para-aortic R 284/640 no Lymphadenectomy Endpoints: OS, PFS, QoL Strata: centre, PS ,age Supported by Deutsche Forschungsgemeinschaft

  23. JGOG-3017 Clear Cell Carcinoma CT vs CDDP + Irinotecan Patients 597/662 Leading JGOG Participating GINECO, GOG, KGOG, MITO, SGCTG

  24. JGOG-3019 iPocc C(3w, IV)T(1w , IV) vs C(3w , IP)T(1w , IV) Patients 3/746 Leading JGOG Participating ?

  25. MITO-7 Weekly CT vs 3-weekly CT (QoL) Patients 315 / 650 Leading MITO Participating MaNGO

  26. MITO-8 LipDox vs CT cross-over in 6-12 m platinum-free interval Patients 72 / 253 Leading MITO Participating MaNGO, AGO-OVAR

  27. Aurelia Bevacizumab plus chemotherapy vs chemotherapy alone in patients with platinum-resistant EOC Patients 226 / 332 Leading GINECO Participating AGO-OVAR, GEICO, MITO, NSGO, BGOG, DGOG

  28. INOVATYON Relapsed ovarian cancer with platinum-free interval (PFI) of 6-12 months Randomization (strata: ECOG, Measurable disease, PFI) PLD 30 mg/m2 1 hour i.v. + Carboplatin AUC 5 30-60 min i.v. on day 1 q4weeks Up to 6 cycles or progression PLD 30 mg/m2 1 hour i.v. + Trabectedin 1.1 mg/m2 3 hoour i.v. on day 1 q3weeks Up to 6 cycles or progression 3rd line chemotherapy: at investigator discretion 3rd line chemotherapy: platinum rechallenge

  29. AGO-OVAR-OP.4 DESKTOP III Cytoreductive surgery vs NO surgery in platinum-sensitive recurrent EOC Patients 3 / 385 activated July 1 Leading AGO-OVAR Participating ?

  30. MucinousEOC oxaliplatin + capecitabine ± bevacizumabvscarboplatin + paclitaxel± bevacizumab Patients 0/332 Leading NCRI/SGCTG GOG Participating AGO OVAR, GINECO, MaNGO, NSGO, KGOG

  31. ICON 8 Patients 1485 Leading MRC Participating ?? C3w P3w vs C3w P1w vs C1w P1w

  32. NCIC CTG OV.21 IP/IV Platinum/P vs IV CP optimally debulked following NACT Patients 0 / 780 Leading NCIC CTG Participating GEICO, NCRI, SWOG

  33. Thank you for attention

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