Pancreatic Cancer

Clinical trials

Clinical trials are research studies involving people. They test how well particular treatments work and whether they are safe. Unless people take part in well designed trials doctors do not have enough evidence to know if a treatment is both effective and safe. Without trials, there is a risk that people will be given treatments which do not work and which may even do harm. There may be great advantages in taking part in a clinical trial. However, just because a treatment is new and is undergoing a trial does not mean it is necessarily better than existing treatments, and it may have bad side effects.

Many of the people we interviewed had taken part in a clinical trial. Some were still involved in the trial and seemed to be doing well, others had decided to leave the trial because of side effects, and some had had to leave the trial because the new treatment was no longer effective.

Clinical trials are performed in a number of stages or phases. When a new treatment is first developed it is given to just a few people to get an idea how safe it is. This is a phase 1 trial. In a phase 2 trial doctors test the new drug in a larger group of people to better measure safety and to see if there are signs of positive effects in patients. Lilian was taking part in a phase 1 trial of combining gemcitabine with, a biological therapy*, a new type of drug called a NOTCH inhibitor that works by decreasing the amount of a protein that some cancer cells need to grow and divide. She attends the clinic once a week for an infusion of gemcitabine and also takes 4 tablets of the new drug. She has attended four times so far and has not yet had any side effects. Ann took part in a phase 1 trial which involved another new type of drug called a PARP inhibitor, a biological therapy*. These drugs can block a protein which is important in DNA repair and so can prevent damaged cancer cells from repairing themselves thereby preventing further growth of the cancer. The side effects made her very ill so she decided to stop the treatment.

Bob had also been involved in a phase 1 trial. He said that only four other people in the country were taking part in the trial, which included the drug Reolysin. This drug has been developed from a reovirus, a biological agent that is found almost everywhere in the environment. The virus has the distinctive ability to replicate within cancer cells and destroy them by causing them to burst open and die, but it doesn't seem to harm normal cells. Bob had a bad reaction to the combination of drugs he was having.

Phase 3 trials are large, and may include hundreds or even thousands of patients. They aim to compare the effects of newer drugs or treatments with the standard treatment if there is one. They provide a better test of whether new treatments work better than existing treatments, and firmer evidence about how common and serious any side effects are. Almost all Phase 3 trials are randomised controlled trials (RCTs) because the doctor wants to know whether the new treatment is any better than the standard treatment. This means that people are allocated at random to one of the groups in the trial, often by using a computer programme. In an RCT, one group of people, the experimental group, is given the new treatment. The other group, called the control group, is given the standard treatment. This approach ensures the patients and doctors do not know who has which drug and so avoid any bias when interpreting the results. Some trials may compare more than two groups.

The European Study Group for Pancreatic Cancer (ESPAC) has been running a number of these trials to see if it is useful to give people adjuvant chemotherapy after surgery. In recent trial (ESPAC 4) some people were having gemcitabine after surgery, while others were having gemcitabine plus capecitabine, to see which treatment has the better outcome.

The ESPAC are also looking at using chemotherapy or chemoradiotherapy before surgery (ESPC-5F study).
 

Many of the people we interviewed had taken part in a phase 3 trial called the 'TeloVac' trial which has since finished. It compared what happened to people having standard chemotherapy with people having chemotherapy and a telomerase vaccine. Immune system cells search for and kill abnormal cells. But they don’t always recognise cancer cells as being abnormal. Vaccines work by teaching immune cells to recognise certain proteins made by cancer cells, in this case the telomerase enzyme, which is more prevalent in cancer cells than normal cells. The immune system cells can then find the pancreatic cancer cells and kill them. Unfortunately, this trial did not show that the vaccine offered any benefit compared with chemotherapy alone. So new approaches are now being explored.

Some of those who had the vaccine had had few or no side effects, but others had quite bad side effects. Rory, for example, had been violently sick when she had the vaccine. Ben was fine at first but after nearly nine months having the vaccine he developed a skin rash. Three months later, after having more vaccine treatment he collapsed.

David (Interview 09) took part in a phase 3 trial that included a drug called erlotinib. This is a biological therapy* called a tyrosine kinase inhibitor. Tyrosine kinases are proteins that cells use to signal to each other to grow. Erlotinib blocks tyrosine kinase within cells from sending growth signals, so the cancer cells don’t grow (a growth factor inhibitor).

Other small trials are now being done to assess the role of imaging. Some include Positron Emission Tomography (PET scans) to see how well conventional chemotherapy is working for people with advanced cancer of the pancreas. This type of scan can show how the body is working, as well as what organs look like. It scans the whole body. With a PET scan people first have an injection of a very small amount of a radioactive drug (tracer). Then people rest for about an hour. This allows the radioactive tracer to spread through the body. The scan produces an image of the radioactive tracer in the body.

Most people told us that they had had enough information, and were glad that they had taken part or were still taking part in a trial, and that the results might help others in the future. They felt that they had been well looked after. They had been able to call the trial nurse at any time to report side effects or ask questions and they had seen a doctor regularly. However, Rory, who was still in the TeloVac trial at the time of her interview, said that she sometimes felt she was just part of a research project; a ‘little bit of a cog in a wheel’.
 

When treatment failed people were naturally disappointed and some had mixed feelings about having taken part in the trial. Some said that when taking part in a trial they (or their relative) had been regarded as ‘data’ rather than ‘a human being’. Bob, who experienced bad side effects (see above), said that he felt he had been a ‘guinea pig’ and that the professionals had been more interested in the trial results than his wellbeing. Ben, who was told he could no longer continue with the vaccine injection in the TeloVac trial because he had bad side effects, felt a bit confused. He was surprised that he no longer saw the doctor monthly or had a regular CT scan. He did not know what was happening and wanted to know more.

For more information about current clinical trials for pancreatic cancer see Cancer Research UK website. For more general information of clinical trials see our website Healthtalk - Clinical trials.

* "A type of treatment that uses substances made from living organisms to treat disease. These substances may occur naturally in the body or may be made in the laboratory. Some biological therapies stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases. Other biological therapies attack specific cancer cells, which may help keep them from growing or kill them. They may also lessen certain side effects caused by some cancer treatments. Types of biological therapy include immunotherapy (such as vaccines, cytokines, and some antibodies), gene therapy, and some targeted therapies. Also called biological response modifier therapy, biotherapy, and BRM therapy.” National Cancer Institute 2015.

 
 

Last reviewed June 2015.
Last updated June 2015.

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