Cancer Trials at Warwick CTU
Dr Jane Warwick
Trial Unit Activity
•Currently 4 in-house programmes of research
•Emergency and Critical Care (Perkins/Gates)
•Musculoskeletal (Underwood/Lamb)
•Orthopaedics (Costa/Griffin)
•Cancer (Dunn)
•Expertise in trial design, health economics & statistics
•Undertake trials in primary & secondary care
•Expertise in trials to assess complex interventions
•Expertise in IMP trials & trials with translational aspect
•WCTU one of 15 members of the NCRI Cancer CTU Group
•Work closely with UKCRC networks, NIHR & NCRI
Levels of CTU support
•
•
•
•
Full management (IT, Stats, HE, SPM, QA,
oversight)
Supported (e.g. stats or HE only with study
management elsewhere)
Service (randomisation and IT only;
subject to capacity and funding)
Other alternatives by arrangement
Cancer Trials
Cancer Trials
Including a new model of NHS sponsored randomised phase II’s:
OPTIMAL – Oxford Churchill NHS Trust
CAB-B1 – UHB sponsored
Peer reviewed, portfolio trials, NIHR NCRI CSG’s
All CI’s MUST go on the training the CI course to understand their responsibilities
Optimal personalised treatment
of early breast cancer using
multi-parameter tests
NIHR HTA funded trial
OPTIMA prelim (£2 million) rolls forward to
OPTIMA main (£3.7 million)
Developed with members of the NCRI CSG
OPTIMA design
Assay
Details of Multi-parametric assay
Oncotype DX
A 21 gene qRT-PCR expression assay (using FFPE
16 cancer related and 5 normalisation genes)
risk score
A 70 gene microarray based expression
signature.
Fresh/
frozen
risk score
A 76 gene microarray based expression
signature; not commercially available.
Fresh/
frozen
risk score
A 50 gene expression assay using RT-PCR or
the nanoString system.
FFPE
subtyping
& risk score
A 7 gene qRT-PCR expression assay
FFPE
risk score
(Genomic Health Inc)
MammaPrint
(Agendia)
Rotterdam signature
(academic)
PAM50
Breast Cancer Index
(bioTheranostics)
Blueprint
(Agendia)
Genomic Grade
(Ipsogen)
Randox Breast Cancer
Array
Material
Test Output
A microarray based assay used in conjunction Fresh/
with MammaPrint
frozen
subtyping
A 97 gene microarray based expression
signature.
Fresh/
frozen
risk score
A 23 gene assay using bio-chip technology
Fresh/
frozen
subtyping
IHC4 (HistoRx & nonproprietary)
Mammostrat(GE Healthcare)
Quantitative immunohistochemical assay for FFPE
ER, PgR, Her2, Ki67
A 5 gene immunohistochemical assay.
FFPE
risk score
NPI plus
A 10 gene immunohistochemical assay.
risk score
FFPE
risk score
The OPTIMA trial team
Oncologists
David Cameron (U Edinburgh)
Helena Earl (Cambridge)
Luke Hughes-Davies (Cambridge) co-CI
Iain MacPherson (Beatson)
Andreas Makris (Mt Vernon) co-CI
Chris Poole (U Warwick)
Dan Rea (U B.ham)
Rob Stein (UCL) co-CI
Surgeon
Adele Francis (U B.ham)
Scientist
John Bartlett (OICR, Toronto)
Health Economics
Chris McCabe (U Alberta)
Peter Hall (U Leeds)
Clare Hulme (U Leeds)
Patient Representative
Adrienne Morgan (IPCV)
Pathologist
Sarah Pinder (KCL)
Mary Falzon (UCLH)
Qualitative Research (U Bristol/ MRC ConDuCT)
Jenny Donovan & Leila Rooshenas
Breast Care Nurse
Vicky Harmer (Imperial Healthcare)
Statistics & Trial Management
Janet Dunn (Warwick CTU)
Andrea Marshall (Warwick CTU)
Amy Campbell (Warwick CTU)
Helen Higgins (Warwick CTU)
Nigel Stallard (U Warwick)
UCL Advanced Diagnostics
Michael Gandy
OPTIMA Tissue Bank (U Edinburgh)
Tammy Robson & Monika Sobol
University of
BRISTOL
Cancer Team Snapshot 2015
Cancer Trial Highlights
• Cougar-2 – demonstrated survival benefit for
patients receiving docetaxel chemotherapy
compared to best supportive care
• AVAST-M – interim analysis showed significant
improvement in disease free interval with the use
of AVASTIN
• ARTemis – demonstrated an improvement in
pathological complete response with the AVASTIN
combination
• OPTIMA prelim – demonstrated trial is feasible,
acceptable and there is VOI for continuing to main
trial
Publications
Lancet Oncol 2015; In Press
Conclusions
• Cancer portfolio is diverse:
• IMPs (novel, combinations & duration), Surgical, Imaging,
gene testing, supportive care, survivorship
•NCRI Cancer CTU Group membership demonstrates
quality
•Multiple sources of funding
•Aim to run trials of national and international importance
•Close liaison with NCRI CSG’s
•University investment in Cancer Research
•New and exciting opportunities