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CANCERWISE- ICORG Article March 20th 2002

Background
The Irish Clinical Oncology Research Group was formed in October 1996, and consists of specialists working in the oncology field who have the common goal of increasing the level of clinical cancer research in Ireland, thereby maintaining and improving all forms of cancer treatment in Ireland. In June of 2000 following agreement with the Northern Ireland Clinical Trials Unit ICORG became an all Island entity. This has very significant repercussions in terms of the ability of this expanded group to obtain significant infrastructure funding under the terms of the tripartite All-Ireland agreement.

Purpose
The purpose of the group is to provide an infra-structural matrix to facilitate the design and conduct of oncology clinical trials. ICORG will provide procedural and practical help to any member or group of members wishing to conduct an executive approved clinical study. The existence of such an organised collaborative group will continue to attract companies developing new oncology drugs and techniques to Ireland and will also provide a mechanism whereby Irish clinicians may investigate their own peer group and ethically approved hypotheses.Members services ICORG central office can and will provide expert help in a number of areas, these include site set up, study initiation and ongoing project management. ICORG will assist with all aspects of the development of the research activities of a specialist’s site. Including for example help with some or all of the following; ethics and regulatory applications, protocol design, monitoring, staff recruitment, training and overall quality assurance. An illustration of one of the elements of study set-up that we look after and our growth and local significance can be seen in the graph below of Irish Medicines Board clinical trial approvals

Current Status of the Group
The growing membership is 135. ICORG currently has opened 46 different protocols and enrolled close to 800 patients. As you can see from the graph below as the group has grown and progressed the time taken for ICORG to enrol 100 patients has consistently reduced. This can be broadly attributed to 3 things 1- the growth in membership, 2- the increase in participation and 3 the growth in the range of studies open for member participation. Studies opened to date fall broadly into the following disease areas: breast, glioblastoma, non Hodgkin’s lymphoma,colorectal, prostate, melanoma, leukaemia, pain-palliation and advanced non-small cell lung cancer. Areas in which more new protocols are anticipated to open before the end of 2002 include: breast, prostate, melanoma, pancreas, lung, gastric and leukaemia among others.

Future Developments
An improving infrastructure and level of resources will enable any member clinician to actively and meaningfully participate in ongoing ICORG clinical research programs or indeed to initiate their own studies through the mechanism of the group. The combined effect of these local improvement throughout the island will be to further grow a reputation for high quality and well organised research for ICORG and its members within Europe and internationally. For Irish patients this will mean continued and growing access to the latest drugs and techniques currently in development.

An update on ICORGs Breast Research Program:
1. Breast International Group (B.I.G.) node positive adjuvant study.
(Supported by Aventis Pharma)
This study looked to determine the optimum adjuvant treatment for node positive breast patients. It was our first major collaborative effort, with 7 Irish hospitals contributing to its success. The Sites and key staff involved were

This joint effort resulted in Ireland being one of the leading contributors worldwide ahead of many of our larger European neighbours:
It is also worth noting that ICORG ended up with two of the top 30 sites worldwide out of a total of 172 active participating centres.
UPDATE:
The 190 patients enrolled in this study are all in follow-up, the nature of the study is such that it will be many years before the main objectives of the protocol can be realised but a preliminary abstracts looking at the early trends may be ready for ASCO 2003.

ICORG and Ireland’s success in the above study, which ran from late 1998 to June 2001 led to a much increased interest in Ireland as a location for top quality multinational research. This together with the fact that one of the key strategists and decision makers in the Breast Cancer International Research Group (BCIRG) was also the founding chairman of ICORG led to an invitation from the BCIRG organisation to ICORG to fully participate in its very exciting and leading-edge breast research program.

2. BCIRG Adjuvant and Advanced Research Program. (Protocols 005, 006 and 007) (Supported by Aventis Pharma)

Adjuvant program.
The key questions being explored by the Adjuvant node positive or high risk node negative study is whether the use of herceptin in this setting will improve time to progressions for patients with her2 overexpressing tumours. The companion study (005) looks to determine the optimal sequence of administration of chemotherapy for patients with node positive tumours that are not candidates for Herceptin. In line with our track record and the growing commitment of the ICORG centres these adjuvant studies are already ahead of ICORGs ambitious projections.

Advanced Program
(supported by Roche)
The so-called 007 protocol looks at the addition of an established compound, Carboplatin to the current widely used treatment for patients with advanced disease which overexpresses Her2 i.e. disease that would routinely be treated with a taxane-herceptin combination. The impetus for this study was the laboratory data which showed both docetaxel and carboplatin to be synergistic to the action of herceptin on Her2 overexpressing cell lines.

Two important points of Irish note on this study are that it is the first international protocol of the BCIRG where the principal chairman is an Irish investigator- John Crown, St. Vincent’s University Hospital and it looks very likely that when it is fully opened it will be ICORGs most widely established study with 13 different locations on the Island taking part.

The study has in recent weeks opened at SVUH and should have all centres on
stream by the Autumn.

3. TEAM study
(Supported by Pharmacia Ltd)
The TEAM study is co-chaired in Ireland by Michael Kerin of the Mater Hospital and Maccon Keane from Galway. It will be opening shortly in 7 centres around the country. It is an open label, randomised comparative trial of 5 years adjuvant Exemestane treatment versus 5 years adjuvant Tamoxifen treatment in Postmenopausal women with Early Breast Cancer Globally, the study will include approximately 4400 subjects from multiple multinational study sites

4. Second Line Advanced disease study
(supported by AstraZeneca)
This study was designed by John Kennedy and John Crown and will be ICORGs first Irish origin phase II in the breast area. The protocol was recently finalised by John Kennedy the studies principal investigator and will enrol its first patients in May of this year. Six Irish Hospitals are taking part :

Beaumont
Cork University
Galway
Mater
St. Vincent’s University
St. James’s

The study is looking at the ability of a novel AstraZeneca agent 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. This new agent is oral and in its early development has so far had a relatively mild side effect profile.

ICORG wishes to thank the Irish Cancer Society and our industry partners for their important support.

For more information: http://www.icorg.ie or Dr Brian Moulton, CEO, Irish Clinical Oncology Research Group, 120 Pembroke Road, Dublin 4 Phone: +353 16621590, .(JavaScript must be enabled to view this email address)