The Irish Clinical Oncology Research Group (ICORG) has launched Ireland’s biggest ever phase II oncology research initiative. Three protocols have been developed by Irish investigators for the treatment of high-risk prostate cancer, and late-stage breast and lung cancer.
The compound involved, IRESSA, has a mode of action distinct from cytotoxic chemotherapies, and is the most exciting new agent in clinical oncology for quite some time.
It is the first in a new class of anti-cancer drugs, known as small molecule, selective EGFR-TKIs (epidermal growth factor receptor-tyrosine kinase inhibitors). These inhibitors in early studies have been shown to have potent anti-tumour activity.
They also have two other important characteristics – a relatively mild side-effect profile in their early clinical development (diarrhoea and skin rashes), and they are administered as a once-daily, oral tablet.
IRESSA targets and blocks, within the cell, signalling pathways that are implicated in the growth and survival of cancer cells. These pathways appear to play a major role in the growth of many solid tumours; therefore, IRESSA may have therapeutic potential in a broad range of common cancers.
The ICORG protocols will be opening for accrual in September 2002; approximately 100 Irish patients will be required to answer each of the three questions.
Dr. John Armstrong, current Chairman of ICORG from St Luke’s Hospital, designed the prostate protocol, while Dr John Kennedy, ICORG Vice-Chairman from St James’s Hospital, is the principal investigator for the metastatic breast protocol. Dr Oscar Breathnach from Cork University Hospital and the Mercy Hospital developed the lung protocol.
Research teams taking part will be lead by: Dr John Armstrong at St Luke’s Hospital; Dr John Crown and Dr David Fennelly at St Vincent’s University Hospital; Dr Oscar Breathnach and Dr Seamus O’Reilly at Cork University Hospital, Mercy Hospital, and South Infirmary; Dr Gordon Mullins at Bon Secours Cork; Dr Maccon Keane in Galway; Dr John Kennedy; and Dr Finbar O’Connell at St James’s Hospital; Dr Liam Grogan at Beaumont; and Dr John McCaffrey and Prof Desmond Carney at the Mater.
The breast protocol will look at the ability of IRESSA to both modulate drug resistance and inhibit tumour progression.
Patients who have failed three specific first-line metastatic therapies will be randomised to either receive their prior chemotherapy again, plus the study drug, or to receive the study drug alone.
The prostate study will compare combined hormonal therapy and radiation therapy with and without IRESSA, while the lung study will look at the combination of IRESSA and weekly taxotere in stage III and IV lung patients.
ICORG – which paid credit to AstraZeneca Ireland for its generous support for the programme – intends to build on the success of these protocols, and this initiative to further grow the reputation of Irish investigators for the design of high-quality clinical trials, and Ireland as a location for high-quality research.