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

TRIAL UPDATE SESSION

Chair: Dr Julie Martyn

ANZGOG ANNUAL SCIENTIFIC MEETING 21-23 March 2013 Broadbeach Queensland

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


I. OPEN TO RECRUITMENT


ANZGOG-1103

Phase I/II BNC105P combination study in partially platinum

sensitive ovarian cancer patients in first or second relapse

Study Chair: Danny RischinProject Manager: Julie MartynStudy Monitor: Kerri CarltonData Manager: David Cannan


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.


Schema


Study ObjectivesPrimary objective Phase 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


Phase I Starting dose

DRUG Units PHASE I STARTING DOSE LEVEL

1 2a +2b +3

BNC105P (mg/m2) 12 16 12 16

CARBOPLATIN AUC 4 4 4 4

GEMCITABINE (mg/m2) 800 800 1000 1000

ANZGOG ANNUAL SCIENTIFIC MEETING 21-23 March Broadbeach Queensland

Current Status•Protocol amendment Dec 2012 to remove omission of D8 gem as a DLTSite Date activated # pts

Peter MacCallum Cancer Centre 19/07/2012 1

Royal Brisbane and Women’s 13/07/2012 3

Royal Prince Alfred 30/07/2012 4

Christchurch 10/08/2012 2

University of Chicago 14/09/2012 0

Indiana University 14/09/2012 2

TOTAL 12 ANZGOG ANNUAL SCIENTIFIC MEETING 21-23 March Broadbeach Queensland

Current Status

Cohort # pts DLT’s

Dose Level 1 6 1 (omission of C1D8 Gem)

Dose level 2a 3 2 (Grade 4 thrombocytopenia)

Dose level 2b 3 0 to date

Dose level 3 Not open


Current Status


Investigator Meeting at 12.30 in Sovereign 2

Working lunch:

12.30-1.00: Phase I Trial Management Committee

1.00-1.30: Presentation for potential Phase 2 sites: Please come and join us.

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 MileshkinStudy Coordinator: Ilka Kolodziej


Schema


ObjectivesPrimary objective: To determine if adding adjuvant chemo to

standard chemoXRT improves overall survivalSecondary 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 healthTertiary objectives:• To collect blood and tissue for future translational studies• To explore the association between complete metabolic response

on post-treatment PET and outcomes


Monthly Recruitment


1/04/2011

1/06/2011

1/07/2011

1/08/2011

1/09/2011

1/10/2011

1/11/2011

1/01/2012

1/02/2012

1/03/2012

1/04/2012

1/05/2012

1/06/2012

1/07/2012

1/08/2012

1/09/2012

1/10/2012

1/11/2012

1/12/2012

1/01/2013

1/02/2013

1/03/2013

0

2

4

6

8

10

12

14

16

18

Months

Pa

rtic

ipa

nts

Current status

• Successful NHMRC Project grant awarded • 2013-17

• 108 Sites open– 15 sites in ANZ– 93 sites in the US

• 143 Patients recruited– 53 patients from ANZ sites– 90 patients from US sites


SAEs

• 51 SAEs reported to date for ANZ sites• Vast majority have occurred during

standard treatment (XRT)• Most SAEs were expected• No SUSARS


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


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 MileshkinTROG Chair: Pearly Khaw

Trial Coordinator: Ilka Kolodziej


Schema

Eligible patients

RANDOMISE

Arm 1 – Control ArmExternal beam pelvic

radiotherapy

Arm 2 – Research ArmConcurrent radiotherapy

& chemotherapy followed by adjuvant

chemotherapy

Pathology review < 1 wk

Max. 8 weeks(From surgery to commencing RT)

Subjects with endometrial carcinomas(informed consent)


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


Treatment

• Control arm – External beam pelvic radiotherapy• Research Arm – Concurrent pelvic radiotherapy and

chemotherapy followed by adjuvant chemotherapy

Chemotherapy• Concurrent: 2 cycles cisplatin 50mg/m2 D1 and 22• Adjuvant: 4 cycles carboplatin AUC 5 + paclitaxel 175mg/m2

Radiotherapy• 48.6 Gy (at 1.8 Gy per fraction)• brachytherapy boost if cervical involvement


SAEs


• Radiotherapy Alone Arm5 reported to date

2 x Radiation enteritis Hypoglycemia/dehydration Small bowel obstruction secondary to adhesions Abdominal pain

•Experimental Arm23 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

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 2012 -

2014• PACT sub-study: most patients filling in questionnaires• TROG Radiotherapy QA is continuing in ANZ • TROG International Radiotherapy QA has commenced


ANZGOG update 2013

Associate Professor Penelope SchofieldTrial Funded by NHMRC. People support: NHMRC research fellowship (CDA 2)

ANZGOG-1102A national, phase III trial

http://www.nhmrc.gov.au/

Investigators & staffChief 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

AimsTo 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

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.

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)


Nurse contact with PSP – concerns &

self-care


self-care

Referrals/info

Nurse session 2(mid-treatment - wk 3)

Nurse session 2(mid-treatment - wk 3)




self-care


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.)




self-care


self-care

Referrals/info


self-care


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 experiencesEncourage adherence to self-care planLink with the nurseProvided 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 orientationSide-effectsSelf-care planCoaching (esp. dilator use) Psychosexual rehabilitationMDT care co-ordinationSurvivorship care plan to pt & GP

One & half days of training & ongoing supervision

Manual includes:• evidence based recommendations,• need assessment tool • self-care brochures.

RecruitmentActivated site N (at 18/03/13) n / month

(average)

Peter Mac – East Melbourne 90 3.4

Peter Mac – Moorabbin 9 1.1

RBWH – Qld 13 0.9

PoW/RHW – NSW 12 1.0

Westmead – NSW 5 0.5

RPA – NSW 3 0.3

TOTAL 132 (require 306) 7.2

Recruitment rate 7/month, estimated 15/month (expected n =210 now)

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

PARAGON

Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic

gynaecological neoplasms

PI ANZGOG: Professor Michael FriedlanderTrial Coordinator: Kim Gillies

Supported By: AstraZeneca Australia


Trial DesignAim -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 SurvivalResponse durationQuality of lifeToxicity

Dosage - Patients are given 1mg anastrozole daily until disease progression, unacceptable toxicity or physician / patient preference.


Trial Schema


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


Current Accrual


Group AccrualANZGOG 116

UK 23TOTAL 139

Nov-10 Apr-12 Aug-13 Dec-14 May-160

50

100

150

200

250

300

350

400

Actual

Projected

Accrual by subtype


Tumour subtypesEpithelial Ovarian, primary peritoneal or fallopian tube - platinum resistant/refractory ovarian tumours

42

Epithelial Ovarian, primary peritoneal or fallopian tube - asymptomatic patients with rising CA125

37

Epithelial Ovarian, primary peritoneal or fallopian tube – Low grade serous

3

Endometrial carcinoma 28Granulosa cell/sex cord stromal tumours 14Endometrial stromal sarcomas/other sarcomas 10To be confirmed 5TOTAL 139

Serious Adverse Events


• 37 SAEs reported to date with 33 of these from Australian & NZ sites• Majority of SAEs were unrelated to study

treatment • No SUSARS

ANZGOG-0701 - Symptom Benefit

Does palliative chemotherapy improve symptoms in women with recurrent

ovarian cancer ?

PI ANZGOG: Professor Michael FriedlanderTrial Co-ordinator: Kim Gillies


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


General Update

• Recruiting very well

• Still generating a lot of interest

• Averaging 30 x participants per monthwill increase with Japan and UK opening

• Due to meet recruitment target - December 2014

• Leading ANZGOG initiated study


Current recruitment status GROUP SITES ACCRUAL

ANZGOG 25 91

CANADA 3 30

AGO 17 39

ICORG 10 42

MITO 20 35

GINECO 19 16

NSGO - Sweden 8 14 (Denmark still to open)

JAPAN 35 Sites opening – 25/03/2013

UK 21 Sites opening – 19/03/2013

USA 1 Due to open – 29/03/2013

TOTAL 159 267


Accrual chart


Aug-

10

Feb-

11

Sep-

11

Apr-

12

Oct

-12

May

-13

Nov

-13

Jun-

14

Dec

-14

Jul-1

50

100

200

300

400

500

600

700

800

900

Actual accrual

Projected accrual

II. PENDING TRIALS


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 DeanProject Manager: Julie Martyn


BACKGROUND

There had been no substantial improvements in outcomes for women with ovarian cancer in the last 15-20 years, until the ground breaking trial by the JGOG was published in the Lancet in 2009. 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.


SCHEMA

1 IPS patients will be randomised after primary surgery 2 DPS patients will be randomised before primary surgery, surgery to be performed between cycles 3 and 4 3 Cycle 3 day 15 chemotherapy to be omitted in patients undergoing DPS.

Newly-diagnosed patients with FIGO IC-IV EOC/PPC/FTC suitable for combination carboplatin-paclitaxel chemotherapy

1:1:1 Randomisation1,2

Arm 1 (control) Carboplatin AUC5 Paclitaxel 175mg/m2 d1 q3w for 6 cycles

Arm 3 Carboplatin AUC2 Paclitaxel 80mg/m2 d1,8,15 q3w for 6 cycles3

Arm 2 Carboplatin AUC5 d1 Paclitaxel 80mg/m2 d1, 8, 15 q3w for 6 cycles


CURRENT STATUS•The first patient was recruited to ICON8 on 6th June 2011•Current accrual is 470 patients out of a total sample size of 1485•65/94 UK sites have been activated •1st GCIG group opened - KGOG. •GICOM (Mexico) and ICORG (Ireland) still to join.•Funding received from Cancer Australia for 2013-15 for ANZGOG participation•Two ANZGOG sub-studies to be included:

Cost Effectiveness Analysis in ANZ setting. Analysis of polymorphisms associated with neurotoxicity


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 FriedlanderProject Manager: Julie Martyn

Trial Co-ordinator: Kerri Carlton


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.


ObjectivesPrimary 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. HRQOLTertiary 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.


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 WalesRoyal Brisbane and Women’sMater Adult BrisbanePeter MacCallum Cancer CentreRoyal Women’s Hospital

• NHMRC/Cancer Australia grant application submitted for funding to commence 2014


Phase II Study of Adjuvant Therapy in CarcinoSarcoma of the Uterus

Dr Bronwyn King, Peter MacCallum Cancer CentreProfessor Peter Grant, Mercy Hospital for Women

Dr Linda Mileshkin, Peter MacCallum Cancer CentreMr Tom Manolitsas, Monash Medical Centre

Professor Michael Quinn, Royal Women’s Hospital

The SACS trial

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

Rationale: Current practice

• Surgery +1. Adjuvant RT2. Adjuvant CT then Adjuvant RT3. Adjuvant RT then Adjuvant CT4. Adjuvant CT then RT then CT “sandwich”

5. Adjuvant CT

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)

Inclusion Criteria• TAH/TLH BSO +/- PLND omentectomy washings

– “Confined to the pelvis”– Involved LNs accepted if below pelvic brim

• FIGO stageIA + 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

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

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)

Update

• Endorsed by Research Advisory Committee ANZGOG 2011

• Funding• Other participating centres• International interest• Protocol

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

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

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

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

Comments welcome

III. TRIALS IN FOLLOW UP


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


• 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


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


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 FriedlanderANZGOG Trial Co-ordinator: Hannah Cahill


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

2013.


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


IV. TRIALS IN CLOSE OUT


CALYPSO

A Multi-National, Randomized, Phase III, GCIG Intergroup StudyComparing Pegylated Liposomal Doxorubicin (CAELYX®) and

Carboplatin vs. Paclitaxel and Carboplatin in Patients with EpithelialOvarian Cancer in Late Relapse (>6 months)

PI ANZGOG: Paul Vasey

ANZGOG Trial Co-ordinator: Kerri Carlton


CALYPSO – current status

• Five papers published in 2012• Final closeout commenced early 2013


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


Current status

• Closed to recruitment – February 2009

• Total recruitment: 1528/76 ANZGOG

• Overall survival data being collected


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


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. 2012 Oct 5.• Final closeout pending


GOG199 – current status

• ANZGOG PI: Dr Kelly-Anne Phillips Peter MacCallum Cancer Centre

• Current status: Follow up complete• Final closeout pending


EORTC 55041 Tarceva: current status

• Primary manuscript submitted to JCO, January 2013• Final closeout pending


TRIPOD

A Single Arm Phase II Trial ofIntraperitoneal Chemotherapy with Paclitaxel and Cisplatin after Optimal Debulking Surgery

for Ovarian and Related Cancers

PI : Michael Friedlander

Trial Co-ordinator: Hannah Cahill


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


Current Status

• The study opened to recruitment in June 2007 and closed to recruitment in December 2009. Patient follow up ceased in January 2012.

• Exceeded minimum recruitment target with 39 patients

• Final publication in progress


ANZGOG Coordinating Centre Update

Julie MartynNHMRC Clinical Trials Centre


ANZGOG and the CTC


•Executive Officer•Group Chair•Board of Directors

ANZGOG University of Sydney

Ops ExecRAC

•Program Manager and trials team•Research Fellows•Oncology co-Director (Martin Stockler)•Biostatistics (Val Gebski)•Clinical Trial Program director (Wendy Hague)

Trials Team


• 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)

Number of patients recruited/year


2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 20130

100

200

300

400

500

600

700

Projected based on 135 pts at week 12/52

2012 milestones


• 3 trials exceeded 100pts – PARAGON, OUTBACK and PORTEC-3

• OUTBACK activated its 100th site• Symptom Benefit recruited its 200th patient• $1,987,863 in grant funding awarded in 2012

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

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