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TRIAL UPDATE SESSION Chair: Dr Julie Martyn ANZGOG ANNUAL SCIENTIFIC MEETING 21-23 March 2013 Broadbeach Queensland.

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Presentation on theme: "TRIAL UPDATE SESSION Chair: Dr Julie Martyn ANZGOG ANNUAL SCIENTIFIC MEETING 21-23 March 2013 Broadbeach Queensland."— Presentation transcript:

1 TRIAL UPDATE SESSION Chair: Dr Julie Martyn ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

2 OUTLINE I: OPEN TO RECRUITMENT ANZGOG-1103: Danny Rischin OUTBACK and PORTEC 3: Linda Mileshkin PeNTAGoN: Penny Schofield Symptom Benefit and PARAGON: Michael Friedlander II: PENDING: ICON-8 and REZOLVE: Michael Friedlander The SACS trial: Bronwyn King III: TRIALS IN FOLLOW UP : Michael Friedlander ICON6, ICON7, OVAR16, GOG182 IV: TRIALS IN CLOSEOUT : Michael Friedlander SCOTROC4, GOG199, TARCEVA, TRIPOD, CALYPSO ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

3 I. OPEN TO RECRUITMENT ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

4 ANZGOG-1103 Phase I/II BNC105P combination study in partially platinum sensitive ovarian cancer patients in first or second relapse Study Chair: Danny Rischin Project Manager: Julie Martyn Study Monitor: Kerri Carlton Data Manager: David Cannan ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

5 Background  BNC105P is a novel vascular disrupting agent (VDA) with promising preclinical activity when combined with platinum or gemcitabine.  Results with platinum based regimens in patients with short progression-free intervals are poor. ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

6 Schema ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

7 Study Objectives Primary objectivePhase I: To determine the: Recommended dose of BNC105P given with gemcitabine and carboplatin (maximum tolerated dose of BNC105P with no more than 1 dose limiting toxicity (DLT) in 6 phase I participants) Phase II: To determine the: Objective response rate (ORR) in those with evaluable disease (ORR = CR, PR according to RECIST 1.1 and/or GCIG CA125 criteria) (percentage of those with measurable disease achieving CR or PR according to RECIST 1.1 and/or GCIG CA125 criteria) Secondary objectives Progression free survival (PFS) and overall survival (OS) Adverse event (AE) rates (G2-5 AE, NCI CTCAE v4.0) Effects on aspects of health related quality of life Correlative objectives Effect of combining these drugs on the pharmacokinetics of BNC105P (cycle 1) Associations between baseline biomarkers, ORR, PFS, OS and AE ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

8 Phase I Starting dose DRUGUnitsPHASE I STARTING DOSE LEVEL 12a+2b+3 BNC105P(mg/m 2 ) CARBOPLATINAUC4444 GEMCITABINE(mg/m 2 ) ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland

9 Current Status Protocol amendment Dec 2012 to remove omission of D8 gem as a DLT SiteDate activated# pts Peter MacCallum Cancer Centre19/07/20121 Royal Brisbane and Women’s13/07/20123 Royal Prince Alfred30/07/20124 Christchurch10/08/20122 University of Chicago14/09/20120 Indiana University14/09/20122 TOTAL12 ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland

10 Current Status Cohort# ptsDLT’s Dose Level 161 (omission of C1D8 Gem) Dose level 2a32 (Grade 4 thrombocytopenia) Dose level 2b30 to date Dose level 3Not open ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland

11 Current Status ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland Investigator Meeting at in Sovereign 2 Working lunch: : Phase I Trial Management Committee : Presentation for potential Phase 2 sites: Please come and join us.

12 OUTBACK A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone Study Chair: Linda Mileshkin Study Coordinator: Ilka Kolodziej ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland

13 Schema ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland

14 Objectives Primary objective: To determine if adding adjuvant chemo to standard chemoXRT improves overall survival Secondary objectives: To determine Progression-free survival rates Acute and long-term toxicities Patterns of disease recurrence The association between RT compliance and outcomes Patient QOL, including psycho-sexual health Tertiary objectives: To collect blood and tissue for future translational studies To explore the association between complete metabolic response on post-treatment PET and outcomes ANZGOG ANNUAL SCIENTIFIC MEETING March Broadbeach Queensland

15 Monthly Recruitment ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

16 Current status Successful NHMRC Project grant awarded Sites open – 15 sites in ANZ – 93 sites in the US 143 Patients recruited – 53 patients from ANZ sites – 90 patients from US sites ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

17 SAEs 51 SAEs reported to date for ANZ sites Vast majority have occurred during standard treatment (XRT) Most SAEs were expected No SUSARS ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

18 Next steps Complete site activations Start trial in India - regulatory approval pending GOG/RTOG sites in Saudi Arabia, Singapore, Brazil all expressed interest Continue recruitment and follow-up ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

19 PORTEC-3 Randomised Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma Study Chair: Linda Mileshkin TROG Chair: Pearly Khaw Trial Coordinator: Ilka Kolodziej ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

20 Schema Eligible patients RANDOMISE Arm 1 – Control Arm External beam pelvic radiotherapy Arm 2 – Research Arm Concurrent radiotherapy & chemotherapy followed by adjuvant chemotherapy Pathology review < 1 wk Max. 8 weeks (From surgery to commencing RT) Subjects with endometrial carcinomas (informed consent) ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

21 Objectives Primary objective Establish overall survival and failure-free survival of patients treated after surgery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone Secondary objectives Establish and compare the rates of: – Treatment-related toxicity – Quality of life – Pelvic and distant recurrence – Preferences for chemotherapy ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

22 Treatment Control arm – External beam pelvic radiotherapy Research Arm – Concurrent pelvic radiotherapy and chemotherapy followed by adjuvant chemotherapy Chemotherapy Concurrent: 2 cycles cisplatin 50mg/m 2 D1 and 22 Adjuvant: 4 cycles carboplatin AUC 5 + paclitaxel 175mg/m 2 Radiotherapy 48.6 Gy (at 1.8 Gy per fraction) brachytherapy boost if cervical involvement ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

23 SAEs ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland Radiotherapy Alone Arm 5 reported to date  2 x Radiation enteritis  Hypoglycemia/dehydration  Small bowel obstruction secondary to adhesions  Abdominal pain Experimental Arm 23 SAEs reported to date Atrial fibrillation 2 x Diarrhoea Neutropenia Anaemia Neuropathy-sensory Lymphocoele Faecal Fistula U-V fistula, urinary incontinence Iliofemoral DVT and PE 2 x Dyspnoea 3 x febrile neutropenia Lymphoedema 2 x Dehydration 2 x Nausea Fever & rash 2 x Fever

24 Current status 104 patients recruited from ANZ (target ~ 120) 577 patients recruited internationally (target 670) 16 sites open in ANZ Successful grant application - Cancer Australia Funding PACT sub-study: most patients filling in questionnaires TROG Radiotherapy QA is continuing in ANZ TROG International Radiotherapy QA has commenced ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

25 ANZGOG update 2013 Associate Professor Penelope Schofield Trial Funded by NHMRC. People support: NHMRC research fellowship (CDA 2) ANZGOG-1102 A national, phase III trial

26 Investigators & staff Chief investigators A/Prof Penelope Schofield, NHMRC Research Fellow / Scientific Director DCER, Peter Mac (CIA) Prof Sanchia Aranda, DCER, Peter Mac / Nursing, U Melb / Cancer Institute NSW (CIB) Dr Ilona Juraskova, Cancer Institute NSW Research Fellow, U Syd (CIC) Dr Linda Mileshkin, Medical Oncologist- Gynae Service, Peter Mac (CID) Dr Meinir Krishnasamy, Nurse Director- Clinical Practice, DCER, Peter Mac (CIE) Prof Kate White, Chair - Cancer Nursing, Nursing, U Syd (CIF) Clinical / Associate Investigators Dr David Bernshaw, Gynaecological Radiation Oncologist, Peter Mac Dr Robyn Cheuk, Snr Radiation Oncologist, Gynae Oncology, Royal Brisbane & Women's Hospital Prof Jonathon Carter, Head- Sydney Gynaecologic Oncology Group, Royal Prince Alfred Hospital Prof Chris Milross, Head – Radiation Oncology, Royal Prince Alfred Hospital Dr Jo Toohey, Radiation Oncology, Royal Prince Alfred Hospital Prof Michael Jackson, Head- Radiation Oncology, Prince of Wales Hospital Prof Neville Hacker, Head of Gynaecological Oncology, Royal Hospital for Women Dr Stephen Thompson, Radiation Oncology, Prince of Wales Hospital Dr Viet Do, Radiation Oncologist, Westmead Hospital Dr Alison Brand, Gynaecological Oncologist, Westmead Hospital Prof Russell Hogg, Gynaecological Oncologist, Westmead Hospital Mrs Sylvia Penberthy, Consumer Representative Dr Amanda Horden, Director- Cancer Information & Support Service, Cancer Council Victoria Ms Alison Hocking, Head- Social Work Dept, Peter Mac Dr Dina Neiger, Director- Biostatistics & Clinical Trials Centre, Peter Mac Prof Madeline King, Cancer Australia Chair of Quality of Life, U Syd Research Staff Rebecca Bergin, DCER, Peter Mac Zahava Wolfowicz, DCER, Peter Mac Suzi Grogan, Cancer Council Victoria

27 Aims To test the effectiveness of a nurse-led psychosocial intervention with peer support to reduce: Psychological distress (anxiety and depression), Informational and psychosocial needs, Psychosexual difficulties, and Symptom distress and improve Quality of life Vaginal health of women receiving radiotherapy for gynaecological cancer

28 Phase III study design Design: –Multi-site RCT –Follow up: prior to first treatment, 1, 6 & 12 months post-treatment Randomisation: –1:1 to usual care OR usual care with the intervention. Stratification: –Treating hospital –Treatment type: external beam RT (+/- brachy) or external beam RT (+/- brachy) PLUS chemo.

29 PSP call 4 (4 wks after end-of-treatment) PSP call 4 (4 wks after end-of-treatment) Nurse session 1 (Pre-treatment) Nurse session 1 (Pre-treatment) PSP call 1 (~1wk after nurse session 1) PSP call 1 (~1wk after nurse session 1) Nurse contact with PSP – concerns & self-care Referrals/info Nurse session 2 (mid-treatment - wk 3) Nurse session 2 (mid-treatment - wk 3) PSP call 2 (~1wk after nurse session 2) PSP call 2 (~1wk after nurse session 2) Nurse contact with PSP – concerns & self-care Referrals/info Nurse session 3 (end-of-treatment: wk6 EBRT, or end of BCY.) Nurse session 3 (end-of-treatment: wk6 EBRT, or end of BCY.) PSP call 3 (~1wk after nurse session 3) PSP call 3 (~1wk after nurse session 3) Nurse contact with PSP – concerns & self-care Referrals/info Nurse contact with PSP – concerns & self-care Referrals/info The Intervention Nurse session 4 (telephone) (2wks after end-of-treatment) Nurse session 4 (telephone) (2wks after end-of-treatment) Peer: Empathy Share experiences Encourage adherence to self-care plan Link with the nurse Provided with side-effects management plan Two days of training & ongoing supervision Manual includes: detailed guide for phone conversations specific topics to cover and effective communication techniques Nurse: Treatment orientation Side-effects Self-care plan Coaching (esp. dilator use) Psychosexual rehabilitation MDT care co-ordination Survivorship care plan to pt & GP One & half days of training & ongoing supervision Manual includes: evidence based recommendations, need assessment tool self-care brochures.

30 Recruitment Activated siteN (at 18/03/13)n / month (average) Peter Mac – East Melbourne903.4 Peter Mac – Moorabbin91.1 RBWH – Qld130.9 PoW/RHW – NSW121.0 Westmead – NSW50.5 RPA – NSW30.3 TOTAL132 (require 306)7.2 Recruitment rate 7/month, estimated 15/month (expected n =210 now)

31 Recruitment solutions New sites –Three interested: Mater Brisbane (Qld), Flinders Medical Centre (SA), Launceston General hospital (Tas). Extend eligibility criteria –Currently only recruiting women who receive external beam RT (+/-brachy or chemotherapy) –Extend to include brachytherapy-only patients

32 PARAGON Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms PI ANZGOG: Professor Michael Friedlander Trial Coordinator: Kim Gillies Supported By: AstraZeneca Australia ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

33 Trial Design Aim -The aim of this study is to assess the activity of anastrozole, in women with oestrogen receptor and/or progesterone receptor positive (ER/PR+ve) potentially hormone responsive recurrent or metastatic gynaecological cancers including selected patients with epithelial ovarian cancer, endometrial cancers, miscellaneous gynaecological sarcomas and granulosa and sex cord stromal tumours of the ovary. Design - This is a single arm, prospective, multi-centre phase II study, grouped by tumour type. Primary Objective - Clinical benefit comprising either response or stable disease. Response as determined by (i) RECIST v.1.1 in patients with measurable disease, (ii) CA125 in patients with ovarian cancer and no measurable disease and (iii) inhibin in patients with granulosa cell tumours with no measurable disease. Secondary Objectives - Progression Free Survival Response duration Quality of life Toxicity Dosage - Patients are given 1mg anastrozole daily until disease progression, unacceptable toxicity or physician / patient preference. ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

34 Trial Schema ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

35 Recruitment Objectives 350 patients across multiple tumour types, determined by response in each sub-group 100 of these patients expected from ANZGOG sites (target exceeded) Recruitment period is 3 years Trial opened December 2011 ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

36 Current Accrual ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland GroupAccrual ANZGOG116 UK23 TOTAL139

37 Accrual by subtype ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland Tumour subtypes Epithelial Ovarian, primary peritoneal or fallopian tube - platinum resistant/refractory ovarian tumours 42 Epithelial Ovarian, primary peritoneal or fallopian tube - asymptomatic patients with rising CA Epithelial Ovarian, primary peritoneal or fallopian tube – Low grade serous 3 Endometrial carcinoma28 Granulosa cell/sex cord stromal tumours14 Endometrial stromal sarcomas/other sarcomas10 To be confirmed 5 TOTAL139

38 Serious Adverse Events ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland 37 SAEs reported to date with 33 of these from Australian & NZ sites Majority of SAEs were unrelated to study treatment No SUSARS

39 ANZGOG Symptom Benefit Does palliative chemotherapy improve symptoms in women with recurrent ovarian cancer ? PI ANZGOG: Professor Michael Friedlander Trial Co-ordinator: Kim Gillies ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

40 Inclusion Criteria Age ≥ 18 years Clinical diagnosis of epithelial ovarian, peritoneal or fallopian tube cancers Recurrent or progressive disease (CA125, radiological or clinical) ECOG PS 0 – 3 Life expectancy > 3 months Planning to commence chemotherapy within 2 weeks of registration Able to complete questionnaires independently ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

41 General Update Recruiting very well Still generating a lot of interest Averaging 30 x participants per month will increase with Japan and UK opening Due to meet recruitment target - December 2014 Leading ANZGOG initiated study ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

42 Current recruitment status GROUPSITES ACCRUAL ANZGOG2591 CANADA330 AGO1739 ICORG1042 MITO2035 GINECO1916 NSGO - Sweden814 (Denmark still to open) JAPAN35Sites opening – 25/03/2013 UK21Sites opening – 19/03/2013 USA1Due to open – 29/03/2013 TOTAL ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

43 Accrual chart ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

44 II. PENDING TRIALS ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

45 ICON-8 An international multi-stage randomised phase III 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 Study Chair: Andrew Dean Project Manager: Julie Martyn ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

46 BACKGROUND There had been no substantial improvements in outcomes for women with ovarian cancer in the last years, until the ground breaking trial by the JGOG was published in the Lancet in This trial showed that women who received weekly paclitaxel in combination with 3 weekly carboplatin, remained disease free for an additional 11 months in comparison with women who received the usual schedule of 3 weekly paclitaxel and carboplatin. It is crucial that these results be confirmed in a non- Japanese population. ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

47 SCHEMA ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

48 CURRENT STATUS The first patient was recruited to ICON8 on 6 th June 2011 Current accrual is 470 patients out of a total sample size of /94 UK sites have been activated 1 st GCIG group opened - KGOG. GICOM (Mexico) and ICORG (Ireland) still to join. Funding received from Cancer Australia for for ANZGOG participation Two ANZGOG sub-studies to be included:  Cost Effectiveness Analysis in ANZ setting.  Analysis of polymorphisms associated with neurotoxicity ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

49 REZOLVE (ANZGOG-1101) A Phase II study to evaluate the safety and potential palliative benefit of intraperitoneal (IP) bevacizumab to control symptomatic ascites in patients with chemotherapy resistant gynaecological cancers Study Co-chairs: Katrin Sjoquist &Michael Friedlander Project Manager: Julie Martyn Trial Co-ordinator: Kerri Carlton ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

50 BACKGROUND Malignant ascites is a common and an important cause of morbidity in patients with chemotherapy resistant gynaecological cancers and there are limited treatment options. The theoretical advantage of intraperitoneal (IP) administration is the high and prolonged concentrations of bevacizumab within the peritoneal cavity. There are laboratory studies to support IP administration as well as some clinical evidence that IP bevacizumab is effective and safe. Aim: To evaluate the activity of IP bevacizumab in symptomatic patients with malignant ascites and chemotherapy resistant gynaecological cancers. ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

51 Objectives Primary Objective: The primary efficacy endpoint of IP bevacizumab is the time to repeat paracentesis (TTP), which is done when clinically indicated and based on patient’s symptoms. Secondary Objectives: 1. To evaluate the safety of bevacizumab via the IP route, 2. To describe the benefit of an additional dose of IP bevacizumab in decreasing or delaying the formation of malignant ascites, 3. HRQOL Tertiary Objectives: 1. To collect and store ascitic fluid to later investigate the mechanisms driving formation of malignant ascites 2. To collect and store blood to later investigate immunological effects of treatment, 3. To provide sufficient data to design and initiate a phase III clinical trial evaluating the efficacy of IP bevacizumab. ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

52 Current status Cancer Institute NSW HREC approved Feb 2013 Site start-up packages to go out shortly to limited sites for pilot phase  Prince of Wales  Royal Brisbane and Women’s  Mater Adult Brisbane  Peter MacCallum Cancer Centre  Royal Women’s Hospital NHMRC/Cancer Australia grant application submitted for funding to commence 2014 ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

53 Phase II Study of Adjuvant Therapy in CarcinoSarcoma of the Uterus Dr Bronwyn King, Peter MacCallum Cancer Centre Professor Peter Grant, Mercy Hospital for Women Dr Linda Mileshkin, Peter MacCallum Cancer Centre Mr Tom Manolitsas, Monash Medical Centre Professor Michael Quinn, Royal Women ’ s Hospital The SACS trial

54 Rationale: What we know Uncommon Aggressive – 5 yr survival 30-40% – Median survival ~ 20mths Recurrence following surgery – 45-50% distant – 45-50% distant + local – 5% local – Most in first 18 mths Adjuvant therapy – No universally accepted standard of care

55 Rationale: Current practice Surgery + 1.Adjuvant RT 2.Adjuvant CT then Adjuvant RT 3.Adjuvant RT then Adjuvant CT 4.Adjuvant CT then RT then CT “ sandwich ” 5.Adjuvant CT

56 SACS Study design: Treatment schema Surgery – TAH, BSO, washings, omentectomy (if carcinosarcoma diagnosis known pre-op) +/-PLND Adjuvant therapy – 2 x Carboplatin (AUC 5-6) +Abraxane (260mg/m2) – WPRT 45Gy +/- boost to vault, +/- boost to involved LN with concurrent Cisplatin 40mg/m2/week x 5 – 2 x Carboplatin (AUC 5-6) +Abraxane (260mg/m2)

57 Inclusion Criteria TAH/TLH BSO +/- PLND omentectomy washings –“ Confined to the pelvis ” – Involved LNs accepted if below pelvic brim FIGO stage IA + myo invasion /IB /II /III (IIIC2 excluded) /IVA Imaging – PET-CT (CT C/A/P if PET unavailable) ECOG 0-2 Life expectancy >6mths Normal organ and marrow function Written consent

58 Exclusion Criteria Any metastatic disease outside pelvis – Except +ve washings Receiving any other investigational agent Existing symptomatic peripheral neuropathy ≥ gd 2 PHx invasive malignancy within last 5 yrs PHx allergy to paclitaxel or carboplatin Serious illness or medical condition that precludes safe administration of trial treatment Unable to provide informed consent

59 Study Summary - Endpoints Feasibility – Recruitment – % patients completing the protocol Efficacy – LR (vault, pelvic nodal or other pelvic recurrence) – DR (PA LN, peritoneal, liver, lung, bone, other) – OS Toxicity – Acute and late (CTC AE v. 4.0) – QOL (EORTC tool)

60 Update Endorsed by Research Advisory Committee ANZGOG 2011 Funding Other participating centres International interest Protocol

61 Trial Logistics Sample size – 50 patients Recruitment – 3 years (17 patients/year) Follow up – Minimum of 3 years 6.5 years total duration from first patient accrual to last patient follow up

62 Funding - $153,000 $138,000 Peter MacCallum BaCT – Trial development – Trial conduct – Trial follow up – Analysis and report preparation $15,000 per patient payments – Peter Mac $0 x 20 patients – 4 other sites $500 per patient x 30pts

63 Funding - $153,000 Specialised Therapeutics Australia – $2000 per patient x 50 = $100,000 – Supply of Abraxane + all related costs – Plus $8000 Peter MacCallum Foundation Grant – $45,000

64 Participating Centres Melbourne (Peter Mac) Sydney (2 sites) – Neville Hacker – Alison Brand Perth (1 site - Sir Charles Gardiner) – Yee Leung, Martin Buck Brisbane (1 site) – Jeff Goh

65 Comments welcome

66 III. TRIALS IN FOLLOW UP ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

67 ICON-6 A randomised trial of concurrent cediranib (with platinum-based chemotherapy) and maintenance cediranib in women with platinum-sensitive relapsed ovarian cancer PI ANZGOG: Dr Michelle Vaughan ANZGOG Trial Co-ordinator: Kerri Carlton ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

68 First site activated January 2011 First patient recruited January 2011 Current status 7 sites activated, 17 patients recruited at 5 sites 12 sites were in the process of activation or about to activate when the recruitment period was shortened by more than two years ICON6 Current status ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

69 ICON6 Current status Following two negative trials using cediranib, AstraZeneca announced in September 2011 they would do no further development of the drug The decision was made to cease recruitment at 470 patients worldwide and the study closed to recruitment early December 2011 Detailed analysis of 430 patients scheduled for April 2013 All ANZGOG patients have now ceased study drug and 13 remain alive ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

70 OVAR-16 A Phase III Study to Evaluate the Efficacy and Safety of Pazopanip Monotherapy versus Placebo in Women who have not progressed after First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancers PI ANZGOG: Prof Michael Friedlander ANZGOG Trial Co-ordinator: Hannah Cahill ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

71 Current Status - Global 941/900 patients recruited Participating countries: Australia, Austria, Belgium, China, Denmark, France, Germany, Hong Kong, Ireland, Italy, Japan, Norway, South Korea, Spain, Sweden, Taiwan, USA Recruitment closed 2 July 2010 Late Breaking Abstract to be submitted for ASCO ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

72 GOG182 – current status Current status: (total recruitment: 183) –Number of patients in follow up: 34 –Number of patients deceased: 138 –Number of patients withdrawn/lost to follow up: 4 –Number of patients excluded: 7 ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

73 IV. TRIALS IN CLOSE OUT ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

74 CALYPSO A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX®) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months) PI ANZGOG: Paul Vasey ANZGOG Trial Co-ordinator: Kerri Carlton ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

75 CALYPSO – current status Five papers published in 2012 Final closeout commenced early 2013 ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

76 ICON-7 A randomised, two-arm, multi-centre GCIG trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer PI ANZGOG: Phillip Beale ANZGOG Trial Co-ordinator: Kim Gillies ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

77 Current status Closed to recruitment – February 2009 Total recruitment: 1528/76 ANZGOG Overall survival data being collected ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

78 SCOTROC-4 Prospective, Multicentre, Randomised Trial of Carboplatin Flat Dosing vs. Intrapatient Dose Escalation as First Line Chemotherapy of Ovarian, Fallopian Tube and Primary Peritoneal Cancers PI ANZGOG: Dr. Geraldine Goss PI UK: Professor Stan Kaye ANZGOG Trial Co-ordinator: Hannah Cahill ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

79 SCOTROC-4 Primary Publication: Banerjee S, Rustin G, Paul J, Williams C, Pledge S, Gabra H, Skailes G,Lamont A,Hindley A,Goss G, Gilby E, Hogg M, Harper P, Kipps E, Lewsley LA, Hall M, Vasey P, Kaye SB. A multicenter, randomized trial of flat dosing versus intrapatient dose escalation of single-agent carboplatin as first-line chemotherapy for advanced ovarian cancer: an SGCTG (SCOTROC 4) and ANZGOG study on behalf of GCIG. Ann Oncol Oct 5. Final closeout pending ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

80 GOG199 – current status ANZGOG PI: Dr Kelly-Anne Phillips Peter MacCallum Cancer Centre Current status: Follow up complete Final closeout pending ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

81 EORTC Tarceva: current status Primary manuscript submitted to JCO, January 2013 Final closeout pending ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

82 TRIPOD A Single Arm Phase II Trial of Intraperitoneal Chemotherapy with Paclitaxel and Cisplatin after Optimal Debulking Surgery for Ovarian and Related Cancers PI : Michael Friedlander Trial Co-ordinator: Hannah Cahill ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

83 TRIPOD Trial Aim - To assess the feasibility, toxicity and effects on quality of life of treatment with a modified GOG 172 regimen in patients with optimally debulked ovarian cancer Primary Objective - To determine the feasibility of giving treatment as prescribed End-points - Feasibility, safety, quality of life ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

84 Current Status The study opened to recruitment in June 2007 and closed to recruitment in December Patient follow up ceased in January Exceeded minimum recruitment target with 39 patients Final publication in progress ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

85 ANZGOG Coordinating Centre Update Julie Martyn NHMRC Clinical Trials Centre ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

86 ANZGOG and the CTC ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland Executive Officer Group Chair Board of Directors ANZGOG University of Sydney Ops Exec RAC Program Manager and trials team Research Fellows Oncology co-Director (Martin Stockler) Biostatistics (Val Gebski) Clinical Trial Program director (Wendy Hague)

87 Trials Team ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland Kim Gillies (Symptom Benefit, PARAGON, ICON7) Ilka Kolodziej (OUTBACK, PORTEC-3) Kerri Carlton (ANZGOG-1103, REZOLVE, ICON6) Hannah Cahill (OVAR16, Symptom Benefit) Lisa Bailey (parental leave) David Cannan (ANZGOG-1103, PARAGON) David Mizrahi (Clinical Trial Admin) Dirkje Sommeijer (Research Fellow) Ann Long (Research Fellow – from Feb 2013) Katrin Sjoquist (CTC Clinical Lead) Julie Martyn (Program Manager)

88 Number of patients recruited/year ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland

89 2012 milestones ANZGOG ANNUAL SCIENTIFIC MEETING March 2013 Broadbeach Queensland 3 trials exceeded 100pts – PARAGON, OUTBACK and PORTEC-3 OUTBACK activated its 100 th site Symptom Benefit recruited its 200 th patient $1,987,863 in grant funding awarded in 2012


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