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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. in press. 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 in press

  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. Calypso Published Ahead of Print on May 24, 2010

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

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

  10. 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

  11. 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, in preparation

  12. Open/PlannedTrials

  13. AGO-OVAR-12 Carbo Paclitaxel +/- BIBF 1120 (Vargatef) Patients 146 / 1300 (2:1 random) Leading AGO-OVAR Participating AGO-Austria, BGOG, GINECO, MANGO, MITO, NSGO, US Oncology

  14. AGO-OVAR 16 Pazopanib consolidation 1 yr First Line Chemotherapy Control Patients 752 / 900 Leading AGO-OVAR Participating AGOAustria, ANZGOG, BGOG, GEICO, GINECO, ICORG, JGOG, KGOG, MANGO, MITO, NSGO, US-Sites: California Consortium, NY GOG, SWOG

  15. 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 184/640 no Lymphadenectomy Endpoints: OS, PFS, QoL Strata: centre, PS ,age Supported by Deutsche Forschungsgemeinschaft

  16. JGOG-3017 Clear Cell Carcinoma CT vs CDDP + Irinotecan Patients 541 / 600 Leading JGOG Participating GINECO, GOG, KGOG, MITO, SGCTG

  17. MITO-7 Weekly CT vs 3-weekly CT (QoL) Patients 227 / 400 Leading MITO Participating MaNGO

  18. MITO-8 LipDox vs CT cross-over in 6-12 m platinum-free interval Patients 46 / 253 Leading MITO Participating MaNGO, AGO-OVAR

  19. Aurelia Bevacizumab plus chemotherapy vs chemotherapy alone in patients with platinum-resistant EOC Patients 110 / 332 Leading GINECO Participating AGO-OVAR, GEICO, MITO, NSGO

  20. AGO-OVAR-OP.4 DESKTOP III Cytoreductive surgery vs NO surgery in platinum-sensitive recurrent EOC Patients 0 / 385 activated June 1 Leading AGO-OVAR Participating ?

  21. CHORUS Upfront Surgery vs Neoadjuvant Chemotherapy Patients 535 / 550 Leading MRC Participating

  22. ICON6A Randomised Trial of Concurrent Cediranib (with Platinum-based Chemotherapy) and Maintenance Cediranib in Women with Platinum-Sensitive Relapsed Ovarian Cancer

  23. Trial Design

  24. Expected vs Actual Accrual

  25. mEOC A multicentre randomised factorial trial comparing oxaliplatin + capecitabine, bevacizumab and carboplatin + paclitaxel in patients with previously untreated mucinous Epithelial Ovarian Cancer (mEOC) mEOC is an intergroup study with two identical protocols from GOG and NCRI with a single analysis Cancer Research UK & UCL Cancer Trials Centre

  26. mEOC/GOG#241 2x2 Factorial Trial Design Mucinous ovarian cancer FIGO stages II–IV OR recurrent stage I; No previous chemotherapy; >18yrs; PS=0-2 Randomise (332 patients – 83 patients in each arm) Oxaliplatin & Capecitabine 6 cycles q 21d Bevacizumab 15mg/kg q3 w 5 or 6* cycles Carboplatin & Paclitaxel 6 cycles q 21d Oxaliplatin & Capecitabine 6 cycles q 21d Oxaliplatin & Capecitabine 6 cycles q 21d Bevacizumab 15mg/kg q3 w 5 or 6* cycles Clinical assessment every 6 weeks for 36 weeks Telephone call at week 3 between every 6-week visit Bevacizumab 15mg/kg q3 weeks for 12 cycles Clinical assessment every 6 weeks for 36 weeks Response assessment: CT scans are carried out post cycle 3 of chemo, 1 month after completion of cycle 6, then 3 monthly for Year 1 Follow up: 3 monthly years 1-2, 6 monthly years 3-5 *Bevacizumab can be omitted from the first cycle of if chemotherapy must be started within 4 weeks of surgery.

  27. An international three-stage randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian cancer.

  28. ARM1: C q 3/52 P q 3/52 (current std) Surgery (IPS) Chemotherapy 6 cycles ARM2: C q 3/52 P q 1/52 Randomisation ARM3: C q 1/52 P q 1/52 Chemotherapy (x 3) Surgery (DPS) Chemotherapy ( x 3) (A) Immediate Primary Surgery (IPS) One trial with pre-specified stratification for IPD v DPS (B) Delayed Primary Surgery (DPS) • Cycle 3 administered as standard 3-weekly cycle in all patients for DPS

  29. Arm 1- Carboplatin AUC5 q3w Paclitaxel 175mg/m2 q3w (standard of care) Arm 2- Carboplatin AUC5 q3w Paclitaxel 80mg/m2 q1w (JGOG 3016 regimen) Arm 3- Carboplatin AUC2 q1w Paclitaxel 80mg/m2 q1w 1485 women recruited over 3 years Treatment Regimens

  30. International randomised phase III study of a PARP inhibitor versus liposomal doxorubicin or topotecan for ovarian cancer patients relapsing following previous platinum therapy and carrying a deleterious germline BRCA1 or BRCA2 mutation 540 patients over 4.5 years with 1 yr FU • Primary variable: • PFS • Secondary variables: • ORR by RECIST • Ca125 response (GCIG) • OS

  31. iPocc Trial IntraPeritoneal therapy for Ovarian Cancer with Carboplatin (GOTIC-001 / JGOG3019) A Randomized Phase II/III Trial of 3 Weekly Intraperitoneal versus Intravenous Carboplatin in Combination with Intravenous Weekly Dose-Dense Paclitaxel for Newly Diagnosed Ovarian, Fallopian Tube and Primary Peritoneal Cancer Study Chair Keiichi Fujiwara Saitama Medical University International Medical Center

  32. Schema Epithelial Ovarian Cancer Stages II-IV Including Bulky Tumor RANDOMIZATION Paclitaxel 80 mg/m2 IV Day1,8,15 Carboplatin AUC 6 IP Q21, 6-8 Cycles Paclitaxel 80 mg/m2 IV Day1,8,15 Carboplatin AUC 6 IV Q21, 6-8 Cycles Dose dense−TCiv Dose dense−TCip Primary Endpoint: PFS Secondary Endpoint: OS, Toxicity, QOL Accrual Goal: 746 pts / 511 events

  33. NCIG CTG OV21 Patients with EOC 3-4 cycles neoadjuvant chemo Initial surgery: < 1 cm residual 3 cycles d1 IV Carbo/Taxol 3 cycles IP/IV d1 CDDP/Carbo IP and Taxol IV d8 IP Taxol 60mg/m2 d8 IV Taxol 60mg/m2 Endpoints: PFS and OS

  34. Diagnostic biomarkers Patients diagnosed with EOC 3-4 cycles neoadjuvant chemo Markers of primary chemoresistance Primary surgery:> 1 cm residual Or patient not entered in OV21 Primary surgery: < 1 cm residual OV21 patient No surgery +/_ progressive disease Specific markers for IP vs. IV Disease progression Markers for acquired chemoresistance

  35. OVATYON Relapsed ovarian cancer (n=588) 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

  36. Thank you for attention

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