Metals in Medicine Consortium
Sydney Cancer Centre
Sydney Cancer Centre
Clinical Oncology Departments of:
• Royal Prince Alfred Hospital
 Medical Oncology
 Radiation Oncology
 Surgical Units (urology, melanoma,
breast, GI, H&N, cardiothoracic, etc)
 Palliative Care
 Haematology
• Concord Hospital
• Dubbo Hospital
SCC Clinical Research Links
• Pharmaceutical Industry
• University of Sydney (Med Psychology,
Chemistry, Pharmacology)
• Australian cooperative groups (disease specific)
• US National Cancer Institute:
US cooperative groups (ph III)
Cornell University phase II consortium (ph II)
CTEP organ dysfunction working group (ph I)
• Other international cooperative groups
Essential Clinical Resources for
Developmental Therapeutics Research
• Clinicians
• Patients
• Clinical research staff
• Regulatory infrastructure
• Laboratory interface
SCC Clinical Capability (Medical Oncology)
A/Prof Michael Boyer
Dr Philip Beale
Dr Jane Beith
A/Prof Stephen Clarke
Dr Anne Hamilton
Dr Lisa Horvath
Prof John Simes
Dr Martin Stockler
Dr Anne Sullivan
Prof Martin Tattersall
• 2000 new patients per year
• 200 patients on clinical trials per year
• 40 active protocols at any point in time
• 12 research staff (nurses / admin) including
RT / Concord / Dubbo
Key SCC Personnel - Metals in Medicine
• Dr Philip Beale
Director, Med Oncology, CGRH/Dubbo
GI, gynae, breast, clin pharm
• A/Prof Michael Boyer
Director, Med Oncology, CSAHS/RPAH
lung, GU, H&N
• A/Prof Stephen Clarke
Head, Clinical Pharmacology
GI, lung, clin pharm
• Dr Anne Hamilton
Head, Clinical Trials
breast, melanoma, gynae, clin pharm
End-points of Phase I studies
• Recommended phase II dose and schedule
• Human toxicology profile
• Pharmacokinetics
• Pharmacodynamics
• Preliminary efficacy data
Role of Clinicians in Developmental
Therapeutics Research
1. Protocol Planning (Registration Strategy)
2. Patient Selection and Treatment
3. Translational Laboratory Research Capability
(“Bench to Bedside”)
4. Imaging Capability
Protocol Planning (Registration strategy)
• selection of schedule / route of administration
• selection of starting dose / dose escalation plan
• selection of monitoring according to knowledge
of toxicities in drugs of same class / preclinical
data
• development of strategies for managing side
effects / problems as they occur
• identification of clinical “niches” for drug
development
• knowledge of competing molecules
Patient Selection and Treatment
• identification of appropriate patients
• informed consent
• drug administration
• monitoring and management of efficacy and
toxicity
• determination of relationship of clinical events
to the study drug
• supportive care
• reporting (regulatory)
Translational Research Capability
“Bench to Bedside”
Concord Laboratory
Cell lines
• In vitro drug activity in sensitive and resistant
cell lines
Animal (xenografts / immune competent animals)
• pharmacokinetics (LCMS)
• pharmacodynamics
• toxicology
• anti-tumour activity
Translational Research Capability
“Bench to Bedside”
Human (pretreated cancer / tumour targeted
population)
• pharmacokinetics (LCMS)
• pharmacodynamics
• PET labelled compounds
(tissue distribution / “real time” PK)