Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of plerixafor for cancer that has spread (CAM-PLEX)
More about this trial
Bowel cancer, ovarian cancer and pancreatic cancer that has spread can be difficult to treat. Doctors usually offer people with these advanced cancers
Plerixafor is a drug currently used in the treatment of people with
The researchers think this may help immunotherapy to work for people with bowel cancer, ovarian cancer and pancreatic cancer that has spread. But they need to know that plerixafor can help the body’s immune cells get into these cancers. To do this they will take samples of cancer tissue (
The aims of this trial are to find out
- The highest safe dose of plerixafor to give
- If plerixafor helps the body’s immune cells get into the cells of these cancers
Who can enter
You may be able to join this trial if you have one of the following cancers that cannot be removed by surgery and is
- Your cancer must be an
adenocarcinoma(your doctor can tell you this)
- If you have ovarian cancer it must be a serous type which is
high grade(your doctor can tell you this)
- You have had the standard
chemotherapytreatment for your cancer that has stopped working (is refractory) or you have declined to have chemotherapy
- You have an area of cancer that a sample of tissue (
biopsy)can be taken from
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 16 years old
You cannot join this trial if any of these apply. You
- Have had chemotherapy in the past 28 days
- Have had steroids, or any other medication that affects your
immune system, in the past 28 days
- Have certain heart problems (the trial team can advise you about this)
- Have an infection
- Have HIV, hepatitis B or hepatitis C
- Are taking part in another clinical trial
- Are allergic to plerixafor, or any of its ingredients
- Have any other medical or mental health problem that the trial team thinks could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 1 trial. There are 2 parts to this trial. For the 1st part researchers need up to 18 people to join.
In part 1 the first few people taking part will have a low dose of plerixafor. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
The 2nd part is only for people who have pancreatic cancer. The researchers need 10 people to join. In this part the researchers will use the best dose found in part 1.
You have plerixafor for 7 days continuously through a PICC line (peripherally inserted central line). The line is attached to a portable pump. You need to go back to the hospital each day for the pump to be changed.
As long as it is helping you and the side effects aren’t too bad you may be able to have 1 additional treatment of plerixafor.
The researchers will ask for some blood samples and a sample of your cancer tissue (
You see the doctor or nurse to have some tests before taking part in the trial. These tests include
- A physical examination
- Blood tests
- Urine test
- Heart trace (
- Recording of the electrical activity of your heart (
- Sample of your cancer tissue (biopsy)
- PET-CT scan
- CT scan or an MRI scan
When you start treatment you need to stay in hospital for 2 days. During this time a recording of the electrical activity of your heart will be done that is similar to the Holter test.
After the 2 days, if your doctor feels you are well enough you can leave hospital. Or if you prefer you can stay in hospital for the entire week of treatment.
If you choose to leave hospital, you will have a Holter test monitor for the remaining days of treatment. You also need to go back to the hospital each day to have the pump changed. The doctor will also do a number of tests including a physical examination, blood tests and urine test. These visits will take about 2 hours.
The day you finish treatment, you see the doctor to have the PICC line removed.
You then see the doctor once a week for the next 3 weeks. If your cancer responded to treatment you have a CT scan or MRI scan in the 2nd week.
The most common side effects of plerixafor are
- Diarrhoea or constipation
- Feeling or being sick
- Indigestion, feeling bloated, passing wind (flatulence)
- Tummy (abdominal) discomfort or pain
- Sore, dry or numb mouth
- Feeling tired (fatigue)
- Problems with sleeping
- Excessive sweating
- Redness, tingling, prickling, pricking or burning feeling of the skin
- Joint, muscle and bone pain
- High temperature (fever)
- Increase in the number of white blood cells in your blood
The trial doctor will talk to you about the possible side effects before you agree to take part.
How to join a clinical trial
Professor Duncan Jodrell
Cambridge Clinical Trials Unit
Cancer Research UK – Cambridge Institute
Experimental Cancer Medicine Centre (ECMC)
NIHR Cambridge Biomedical Research Centre
Sanofi Aventis (UK)
Stand Up to Cancer (SU2C)
The Lustgarten Foundation
University of Cambridge