National cancer trial launched in Wales today
10 February 2005
A national bowel cancer trial has been launched in Cardiff today, 10 February. It is hoped the results of the trial will provide doctors with improved treatments for people with bowel cancer. The research is being funded by the Medical Research Council (MRC) and Cancer Research UK, with an educational grant from the pharmaceutical company, Merck KGaA.
The COIN* trial will try to find out whether using a new treatment called cetuximab as a supplement to normal chemotherapy will increase the number of patients whose tumours shrink and if it can help control the cancer for a longer period of time. Cetuximab has already been found to be effective in patients with bowel cancer, when conventional chemotherapy has been unsuccessful. The researchers will also look at whether 12-week courses of chemotherapy with planned breaks, instead of the typical continuous courses, can reduce the side effects of chemotherapy.
It is hoped that almost 2,500 nation-wide bowel cancer patients will take part in the trial. In addition to receiving the usual best medical care, patients will be randomly assigned one of three treatment plans:
Plan A is the current established treatment and involves chemotherapy being given on a regular basis for at least six months, if the cancer has been stabilised or is shrinking.
Plan B is a treatment where chemotherapy will be given as in Plan A, but patients will also receive cetuximab every week intravenously. This treatment will continue if the cancer has been stabilised or is shrinking.
Plan C is continuous intermittent chemotherapy, where chemotherapy is given for 12 weeks and then treatment stopped. Patients in this group will be closely monitored and when the cancer shows any signs of activity treatment will be restarted on another 12-week course.
Patients entering COIN will be monitored very closely to assess how their cancer is responding. This will include being seen by a doctor and having blood tests every six weeks while on treatment and having CT scans every 12 weeks.
Professor Tim Maughan, Director of Wales Cancer Trials, will head the trial. He said: “Cetuximab targets the cancer and appears to make standard chemotherapy much more effective, we want to find out if it can help patients to live longer and have a better quality of life.
“The trial also addresses chemotherapy, which is arduous and tiring for patients. We hope to discover that using chemotherapy intermittently will be as effective as the current continual treatment, meaning patients would be able to have a break from the treatment for recovery and holidays.
“We will also be doing a range of very sophisticated tests on people’s blood samples and tumour samples, which will help us see whether we can predict which patients will respond best to the treatment, and who might do better with an alternative approach.
“As always our main priority is to ensure that patients taking part in the trial receive the highest standard of support and care.”
Previous cancer patient at the Velindre Cancer Centre in Wales, Malcolm Pope, talks about his experience of assisting with a cancer trial: “I found that being involved in a cancer trial had many advantages; I received excellent information throughout and was closely monitored and asked to keep a daily diary to record my progress.
“I had access to a new drug and, following the trial, the standard treatment for other patients with this condition has improved.”
Any patients interested in taking part in the trial need to speak to their treating clinician to see if they are eligible.
With one of the worst cancer mortality rates, bowel cancer kills some 16,000 people in the UK alone each year. (Cancer Research UK Mortality Statistics 2003 UK)
For further information, or to arrange an interview, contact the MRC press office on 0207 637 6011
Professor Maughan will be available for interviews between 9.00 am and 10.30 am on Thursday 10 February 2005 and all day on Friday 11 February 2005
*A three arm randomised controlled trial comparing continuous chemotherapy plus cetuximab or intermittent chemotherapy with standard continuous palliative combination with oxaliplatin and a fluoropryimidine in first-line treatment of metastatic colorectal cancer.
Notes to Editors
Trial Procedure
- Volunteers entering the trial will be asked for their permission for laboratory tests to be done on a blood sample and on a tissue sample from their cancer to help find out which treatments patients are most likely to respond to.
- Entry to the trial is voluntary and anyone who takes part is free to withdraw at any time.
Cetuximab
Cetuximab (which is also known as Erbitux TM) is a new treatment which has been found to be effective in patients with bowel cancer when used after other chemotherapy has been unsuccessful. It is now licensed for use in the UK in combination with irinotecan for patients whose tumour has a specific protein on the surface. In the COIN trial we are trying to find out whether adding it to the first line chemotherapy treatment will increase the number of patients whose cancer shrinks and whether it will help control the cancer for a longer period of time. Preliminary data shows that it can safely be combined with oxaliplatin plus 5FU chemotherapy and that it did result in the cancer shrinking in more patients than we usually see with chemotherapy alone.
Cetuximab is not a traditional chemotherapy agent, it is a synthesised antibody (a substance formed normally by the body to help defend itself against infection) targeted towards tumour cells and therefore does not have the same profile of side effects that are traditionally experienced with chemotherapy. Cetuximab is a monoclonal antibody. Cetuximab is a pure antibody that recognises and attaches to its target (called the epidermal growth factor receptor, EGFR) on the surface of the cancer cells. When this happens it may slow down or even stop the growth of cancer cells and may increase the benefit of chemotherapy. It is given once a week as a drip lasting 1-2 hours.
Clinical Trials
- A clinical trial is a research study which involves people to find out which treatment works best.
- The more people who enter clinical trials, the sooner the most effective treatments can be introduced to all cancer patients.
- Patients on trials are monitored very closely.
MRC
The Medical Research Council (MRC) is a national organisation funded by the UK tax-payer. Its business is medical research aimed at improving human health; everyone stands to benefit from the outputs. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and the academic world. MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. About half of the MRC’s expenditure of £450 million is invested in its 40 Institutes, Units and Centres. The remaining half goes in the form of grant support and training awards to individuals and teams in universities and medical schools.
Cancer Research UK
Visit the website CancerHelp UK (www.cancerhelp.org.uk) for clear, easy to understand information about cancer, trials and cancer treatments. Cancer Research UK’s vision is to conquer cancer through world-class research. The charity works alone and in partnership with others to carry out research into biology and causes of cancer, develop effective treatments, improve the quality of life for cancer patients, reduce the number of people getting cancer and providing authoritative information on cancer. Cancer Research UK is the world’s leading charity dedicated to research on the causes, treatment and prevention of cancer. For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0207 009 8820 or visit www.cancerresearchuk.org
Merck
Merck is a global pharmaceutical and chemical company with sales of EUR 7,2 billion in 2003, a history that began in 1668, and a future shaped by 28,300 employees in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 74% interest and free shareholders own the remaining 26%. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917.
