Val Lishman Health Research Foundation Inc » Current Research

Clinical cancer trials are conducted world-wide and contribute to the establishment of new and improved treatment regimes for cancer. As a direct result of increased medical knowledge gained from clinical cancer trials, some leukaemias are now cured, and survival rates are improving for a number of cancers, including that of the breast and bowel. As a direct benefit of trial research, it is now possible to treat some cancers with less invasive surgical methods.

To ensure reliable results, collaborative international clinical cancer trials generally involve hundreds of hospitals and thousands of volunteer patients. Traditionally, these trials have been conducted by big city teaching hospitals. However, this traditional method of conducting trials has not been able to keep up with the increased demand for assessment of new cancer treatments. The Cancer Council of Western Australia and the West Australian Clinical Oncology Group approached the Val Lishman Health Research Foundation Inc in an attempt to set up trials in the South West of Western Australia, an initiative that may be used as a role model for other regional centres. After extensive accreditation and approval processes, and a major community fund raising effort, the establishment of clinical cancer trials in the South West region has been achieved.

How clinical trials are organised

The process begins with major government-funded bodies like the NHMRC or sometimes major drug companies, commissioning world experts to select the best research ideas. A lead institution, usually a big hospital, is funded to manage the trial and to provide detailed instructions to other participating hospitals. This process ensures that all participating hospitals use identical research and treatment procedures. Hospitals participating in the trials must reach international standards for accreditation and are also audited during trials. Patients who volunteer to enter a trial are protected by independent and rigorous ethical controls. If one treatment proves to provide better outcomes than another, the trial ends immediately.

Patients and clinical cancer trials

Not all cancer patients will be suitable for clinical trials. Patients need to meet strict eligibility criteria before they are able to enter a trial. For example, people with a second serious illness might not qualify. Patients meeting eligibility criteria and who are interested in participating in a trial receive full information on standard treatments as well as the new treatment method under trial. Patients are encouraged to take time to consider their preferred course of action and to ask questions about the trial. Patients cannot choose which treatment they wish to receive in a trial - the way in which research is conducted means that the actual treatment given to each participant is selected by chance. Patients are only admitted to the trial if they do not mind which treatment they receive. It is important to note that one treatment is not known to be superior to another treatment in a clinical trial; both treatments are based on the best available medical knowledge. Once the treatment phase of the trial is finished, rigorous and intensive aftercare makes sure all the advantages and disadvantages of both treatments are fully recorded. All results are relayed to the trial organisers, who continuously assess progress and report to participants until the research is completed, and either a difference or no difference between compared treatments is proved.

It is important that clinical trials related to cancer research generate answers that are reliable and do not take too long to become clear. This is achieved by working out in advance how many people need to enter a trial for a useful answer to become apparent within a given time frame. The number of hospitals invited to participate in any given trial is largely dependant on the number of participants that are required.

Every person volunteering to enter a trial agrees to regular intensive check-ups for a specified period of time, even if they are feeling fine. Results of the checks are collated and analysed frequently. The trial stops as soon as there is a noted difference between the treatments that is unlikely to be due to chance. A trial may also be closed immediately if one of the treatments being tested causes frequent unexpected complications.

Scope and current status of the research

Trials commenced at the St John of God Health Care Medical Center at the South West Health Campus (Bunbury) in March 2004. Dr Martin Buck is the principal investigator for each trial and bears responsibility to the trial organisations. A Research Nurse advises possible patient volunteers, assists clinicians and manages trial data. The Research Nurse receives special training for each trial, passing this knowledge on, and so enhancing South West Regional research skills. Currently six trials have been entered, of which three are currently active and three await activation. Two additional trials are being entered into at present, including a new surgical trial.

Phase 3 trials occur when a new treatment is released for public use, but only under a carefully observed trial situation. This enables the effectiveness of trial treatments to be confirmed and any unforseen problems to be identified. Currently, all our trials are Phase 3.

What follows is a "lay person's guide" to our experiences managing trials at the South West Health Campus to date.

ANZ Breast Cancer Trials Group

IBCSG 24-02: Pre-menopausal women undergoing curative treatment for a cancer that tests have shown to be hormone receptor positive are eligible to participate. The trial compares a new treatment, "Exemestane in combination with ovarian function suppression", to "standard hormonal treatment". The trial opened in June 2005. There are currently 4 participants. Due to the multiple and complex nature of completing report forms, the trial has contributed to a large work load for the Research Nurse.
ISCSG 23-01: To be eligible to participate in the trial, patients have had a cancer removed from the breast and the "Sentinel" node removed shows only occasional microscopic cancer cell deposits, making it unlikely that there is any involvement of other nodes under the arm. The trial compares "removal of the under arm nodes" (current method) with "no removal, but ongoing observation of the nodes" (probably as effective and removes the need to have an operation). Ethical approval for the trial was granted in May 2006, however, negotiations are proceeding between the trial sponsor and the hospital's legal team to establish an appropriate contract that complies with organisational requirements.
CASA ISCSG 32-05: To be eligible to participate in the trial, patients need to be over 66 years of age, not suitable for a standard course of chemotherapy, and undergoing curative treatment for a cancer that is not hormone-responsive. The trial compares "no additional treatment" to "Adjuvant Pegulated Liposomal Doxorubicin". Ethical approval for the trial was granted in December 2006. The trial contract is also under legal review.
ANZ 0001: Patients with advanced breast cancer are eligible to participate. The trial compares "Capecetabine" (a treatment that can be taken at home by mouth) with "CMF" (a current in-hospital intravenous treatment). Four participants from the South West entered the trial before it was closed to new entrants in July 2005 because there were a sufficient number of volunteers entered into the trial. If the new treatment (Capecetabine) is better or not worse than the current treatment (CMF), it will be preferred because it is much easier and less inconvenient for patients to be treated at home. Results are now being followed closely, and to date, are yet to be finalised.

AGITG Trials Group

AG0103CR (Da Vinci): Patients who have had colorectal cancer previously treated with one prior chemotherapy treatment regime are eligible to participate. The trial compares the "standard treatment with Irinotecan" to "Irinotecan in combination in combination with 5-Fluorouracil and Leucovorin". "Celecoxib" was initially included as part of the trial treatments. It was initially developed for arthritis sufferers and found to have protective benefits against colorectal cancer. The trial was still being devised when news that Celecoxib may be associated with an increased risk of heart attack became evident. Celecoxib was withdrawn from general use and that part of the trial was suspended. The trial opened in March 2006 and there are currently 7 participants entered into the trial. The South West CAmpus is second only to Sir Charles Gairdner Hospital in recruiting for this study. The national target for entrants into this trial is 100.
QUASAR 2 multinational: Patients receiving additional treatment for cure of colon cancer after surgery are eligible to participate. The trial compares "Capecitabine" to "Capecitabine in combination with Bevacizumab". It is expected that the trial will be activated in February 2007. No trial centre has commenced recruitment as yet. The trial's sponsor is finalising their contract.
WYETH 3066A1-303-WW: Post menopausal women with an advanced hormone-responive tumor are eligible to participate. The trial compares "CCI-779 in combination with Letrozole" to "Letrozole"(standard treatment). 1 participant entered the trial. The trial closed to recruitment in March 2006 due to undesirble effects found with CCI-779 upon analysis of interim data.

Implications of the research

Despite being costly, the benefits of clinical cancer trials far outweight their costs. Clinical trials being conducted in the South West may lead to:

an increased contribution to trials by Western Australia, which at the moment, lags behind other states
ensuring local medical staff are aware of recent advances and best practice in relation to cancer treatments
contributing to world progress in cancer treatment
top professional staff being attracted to medical facilities in the South West
empowering patients who wish to contribute to the fight against cancer

Funding

Fundraising for the clinical cancer trials commenced in 2002. By the end of 2004 funds were sufficient to cover expenses for the first three years of the trials. Supported by community donations, the Val Lishman Health Research Foundation Inc coordinates the project, fundraises and manages finances, and reimburses the Research Nurse's salary for actual research time.

The Val Lishman Health Research Foundation Inc especially thanks the

Piacentini Family

for their generous support of this research.

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