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OVARIAN CANCER COMMITTEE Phillipp Harter / Christian Marth

OVARIAN CANCER COMMITTEE Phillipp Harter / Christian Marth. AGO – OVAR OP.3 (LION). L ymphadenectomy I n O varian N eoplasms. epithelial invasive ovarian cancer FIGO IIB - IV ECOG 0/1 and no CI against LNE no visible extra- and intra-abdominal tumor residuals

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OVARIAN CANCER COMMITTEE Phillipp Harter / Christian Marth

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  1. OVARIAN CANCER COMMITTEE PhillippHarter / Christian Marth

  2. 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 80/ 640 no Lymphadenectomy Endpoints: OS, PFS, QoL Strata: centre, PS ,age Supported by Deutsche Forschungsgemeinschaft

  3. AGO-OVAR-12 Carbo Paclitaxel +/- BIBF 1120 (Vargatef) Patients 0 / 1300 (2:1 random) Leading AGO-OVAR Participating AGO Austria, BGOG, GINECO, MANGO, MITO, NSGO, US Oncology

  4. AGO-OVAR12 C C C C C C C C C C C C = Vargatef 2 x 200 mg po qd T T T T T T T T T T T T R C = Carboplatin AUC 5-6 d1 T = Paclitaxel 175 mg/m2 (3h) d1 = Placebo  120 weeks Multicenter, randomised, double-blind, Phase III trial to investigate the efficacy and safety of Vargatef (BIBF 1120) in combination with standard treatment of carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel patients with advanced ovarian cancer SURGERY Vargatef / Placebo : - nointake on daysofchemotherapy - dose: 200 mg pobid (combi + mono) - dose adaptation in caseofunduetoxicity - max. durationof 120 weeks in non-progressingpts q21d / 6 courses n=1300

  5. AGO-OVAR 16 Pazopanib consolidation 1 yr First Line Chemotherapy Control Patients 80 / 900 Leading AGO-OVAR Participating AGO Austria, ANZGOG, BGOG, GEICO, GINECO, ICORG, JGOG, KGOG, MANGO, MITO, NSGO, US-Sites: California Consortium, NY GOG, SWOG

  6. AGO-OVAR16 A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have not Progressed after First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Follow-up Period Treatment Period Post-Treatment Period Screening Baseline RANDOM I ZE Pazopanib (12 months) Observation (to PD) First-line Chemotherapy (allow ip, neoadj) Survival Follow-up (post-PD) If not PD Placebo (12 months)

  7. HECTOR Carbo Topo vs Chemo (CT or CG) in recurrent Platinum-sensitive ovarian cancer Patients 508 / 550 Leading NOGGO/AGO-OVAR Participating AGO-AUSTRIA, GEICO

  8. JGOG-3017 Clear Cell Carcinoma CT vs CDDP + Irinotecan Patients 416 / 652 Leading JGOG Participating GINECO, GOG, KGOG, MITO, SGCTG

  9. JGOG3017/GCIG Ovarian Trial Protocols Randomized Phase III Trial of Paclitaxel plus Carboplatin (TC) Therapy versus Irinotecan plus Cisplatin (CPT-P) Therapy as a First Line Chemotherapy for Clear Cell Carcinoma of the Ovary Study Chair Toru Sugiyama, MD (Iwate Medical University) Study Co-Chair Seiji Isonishi, MD (Jikei University School of Medicine) Fumitoshi Terauchi, MD (Toho University)

  10. International Cooperative Phase III Study for Clear Cell Carcinoma TC Paclitaxel 175 mg/m2 (d1) Carboplatin AUC 6 (d1) Every 3 wk x 6 -Clear Cell Ca -Stage I~IV RANDOMIZATION CPT-11/CDDP CPT-11 60 mg/m2 (d1, 8, 15) Cisplatin 60 mg/m2 (d1) Every 4 wk x 6 225 patients in each arm, 450 total for 3 years 326patients in each arm, 652total for4.25 years

  11. JGOG3017/GCIG Trial

  12. MITO-7 Weekly CT vs 3-weekly CT (QoL) Patients 72 / 500 Leading MITO Participating MaNGO, AGO-OVAR

  13. Trial design • Aim of the trial is to compare the quality of life of weekly somministration of carboplatin plus carboplatin (experimental arm) versus every 3 weeks administration of the same drugs (standard arm) in 1°-line advanced ovarian, tubal and peritoneal cancer Carboplatin AUC 6 Paclitaxel 175 mg/mq day 1 - every 21days RANDOM Carboplatin AUC 2 Paclitaxel 60 mg/mq day 1,8 15 - every 21days

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

  15. Trial design • The objective of this trial isthe efficacy determined through analysis of overall survival (OS) of the different sequence (CP→PLD vs PLD→CP) in recurrent ovarian cancer patients with platinum-free interval 6-12 months RANDOM LIPOSOMAL DOXORUBICIN 40 mg/mq day1 every 28 days CARBOPLATIN AUC 5 + PACLITAXEL 175 mg/mq day1 every21gg Cross-over at Progression LIPOSOMAL DOXORUBICIN 40 mg/mq day1 every 28 days CARBOPLATIN AUC 5 + PACLITAXEL 175 mg/mq day1 every 21 days

  16. ICON6: A randomised trial of concurrent (with platinum based chemotherapy) and maintenance cediranib (AZD2171, Recentin) in women with platinum-sensitive relapsed ovarian cancer. Gynaecologic Cancer Intergroup Trial Stage 1 MRC/NCRI, NCIC Stage 2 ANZ-GOG, IMN, EORTC, GINECO, GEICO, MANGO, NSGO, ICMB and others

  17. Arm B Chemotherapy Plus cediranib during Chemotherapy Arm C Chemotherapy plus cediranib during Chemotherapy Arm A Reference arm 6 cycles of chemotherapy plus Placebo No Progressive disease Placebo Maximum 18 months from randomisation No Progressive disease Placebo Maximum 18 months from randomisation No Progressive disease Maintenance cediranib after chemotherapy Maximum 18 months from randomisation ICON 6 Design schema 2:3:3 RANDOMISATION

  18. ICON6 Cediranib Dose Reduction • Cediranib dose initially selected at 30mg/d in ICON6. Reduced to 20 mg • Stage I re-started • Stage I now completed 103 patients entered (11 UK; 6 CDN) • Stage II being prepared with expansion of chemotherapy options to be discussed by ITMG Sunday 11th Oct- Belgrade

  19. Planned Trials

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

  21. AGO-OVAR-OP.2 DESKTOP II 08/06 – 03/08: Screening of 516 ptswith platinum-sensitive relapse in 46 centres Study collective: AGO score + 1st relapse 129 pts (87%) Score positive + First relapse 76% Complete resection Frequency of complete resection by applying the AGO Score

  22. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4) A randomized trial evaluating cytoreductive surgery in patients with platinum-sensitive recurrent ovarian cancer • Completeresectionseemsfeasibleand a positive AGO-score • Strata: • Platinum-free-interval • 6-12 vs > 12 months • 1st lineplatinum • basedchx: yesvsno Cytoreductive surgery R A N D O M platinum-based chemo-therapy* recommended nosurgery

  23. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4) The next steps: Protocol finalized (-> review participating groups) Ethical approval for Germany:12/09 -> FPI 01/2010 Identifikation of interested GCIG-groups/single centres -> representatives contact: p.harter@gmx.de office-wiesbaden@ago-ovar.de Again limited funding - participating groups have to pay local costs (DESKTOP II model – Presentation/Publication/Co-authorship)

  24. Collaborative Nursing Study MITO12Pathway to diagnosis of ovarian cancer in Italian women: an exploratory study Primary Objectives • Describe the frequency and duration of symptoms in the 12 months preceding the diagnosis of ovarian cancer (Goff symptoms survey) • Describe time intervals of sentinel events • Onset of persistent symptoms • First physician visit • Diagnosis of ovarian cancer • Describe the pathway to diagnosis according to Andersen’s model of “total patient delay”

  25. MITO - 11 Weekly Paclitaxel vs weekly Paclitaxel and Pazopanib in patients with resistant/refractoryovarian cancer: Phase II randomized multicenter trial

  26. Trial design • Aim of the trial is to compare the PFS of weekly paclitaxel vs weekly paclitaxel and pazopanib Paclitaxel 80 mg/mq day 1, 8, 15 - every 28 days RANDOM Pazopanib 800 mg/day Paclitaxel 80 mg/mq day 1,8 15 - every 28days

  27. JGOG IP Trial IP vs IV carboplatin + weekly Paclitaxel Patients Leading JGOG Participating

  28. iPocc Trial Design Epithelial Ovarian, Peritoneal, Fallopian Tube Cancer Stages II-IV Optimal, Suboptimal Excluding Clear Cell Carcinoma Randomization Paclitaxel 80 mg/m2 IV Weekly Carboplatin AUC 6 IV Q21, 6-8 Cycles Paclitaxel 80 mg/m2 IV Weekly Carboplatin AUC 6 IP Q21, 6-8 Cycles Primary Endpoint: PFS Secondary Endpoint: OS, Toxicity, QOL, Cost

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

  30. mEOC Targets:Planned start date – November 2009; Planned end date – May 2014 European Sites: Interest from sites in UK, Denmark, Finland, Sweden, Norway, France, Italy & Germany. Approximately 40 UK sites interested. Trial is in set-up, no centres are open. Chief Investigator: Prof. Martin Gore Sponsor: University College London http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4667 Contact Email: mEOC@ctc.ucl.ac.uk Cancer Research UK & UCL Cancer Trials Centre

  31. ICON-8 TC dose dense / 3weekly ± BEVACIZUMAB Patients 0 / 2000 Leading MRC/NCRI Participating ?

  32. Current Proposal (A) Immediate Primary Surgery (IPS) ARM1: C q 3/52 P q 3/52 (current std) Surgery (IPS) Chemotherapy (ARM 1-3 x 6) ARM2: C q 3/52 P q 1/52 Randomisation One trial with pre-specified stratification for IPD v DPS (B) Delayed Primary Surgery (DPS) ARM3: C q 1/52 P q 1/52 Chemotherapy (Arm 1-3 x 3) Surgery (DPS) Chemotherapy (Arm 1-3 x 3) Plan to use lower dose of paclitaxel than JOG for arm 2: Carboplatin AUC6 d1Paclitaxel 60mg/m2 d 1,8,15 q3w JOG study 60% received 6 cycles, 48% required at least one dose reduction and 76% had at least one delay, doses used carboplatin AUC6 and paclitaxel 80 mg/m2

  33. NCIC CTG OV.21 IP/IV Platinum/T vs IV CT optimally debulked following NACT Patients 0 / 780 Leading NCIC CTG Participating GEICO, NCRI, SWOG

  34. Basic Design Patients with EOC Optimal Surgery 3-4 cycles neoadjuvantchemo Shorter course Initial surgery: < 1 cmresidual R 3 cycles IVCarbo/Taxol 3 cycles IP/IV platinum and taxol Day 8th Day 8th Endpoints: PFS and OS

  35. Phase II

  36. Phase III

  37. DDPC-PREOC A randomised phase III trial of weekly carboplatin and paclitaxel versus pegylated liposomal doxorubicin in recurrent, platinum resistant, epithelial ovarian cancer Patients 0 / 250 Leading SGCTG Participating ?

  38. Carboplatin (AUC 3) and paclitaxel (80 mg/m2) for 3 weeks out of 4 for 6 cycles RANDOMISE 250 patients with platinum resistant disease Pegylated Liposomal Doxorubicin (40 mg/m2) every 4 weeks for 6 cycles Trial Design PrimaryEndpoint: PFS Secondary Endpoints: Overall Survival Quality of Life Health Economic Analysis Response Rate Toxicity/Hypersensitivity Dose Intensity Post progression therapy

  39. Thank you for attention

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