A trial of plerixafor for cancer that has spread (CAM-PLEX)

Cancer type:

Bowel (colorectal) cancer
Ovarian cancer
Pancreatic cancer

Status:

Open

Phase:

Phase 1

This trial is looking at a drug called plerixafor for cancer that has spread. The trial is for people who have

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 chemotherapy Open a glossary item. Another possible treatment may be immunotherapy. Open a glossary item

Plerixafor is a drug currently used in the treatment of people with non Hodgkin lymphoma Open a glossary item and myeloma Open a glossary item. Recent laboratory studies have shown that plerixafor may help the body’s own immune cells, such as T cells, get into the cancer cells.

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 (biopsies) Open a glossary itemand blood samples from people with these cancers before and after they have had plerixafor.

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 locally advanced  Open a glossary item or spread to another part of the body

And

  • Your cancer must be an adenocarcinoma Open a glossary item(your doctor can tell you this)
  •  If you have ovarian cancer it must be a serous type which is high grade Open a glossary item (your doctor can tell you this)
  • You have had the standard chemotherapy Open a glossary item treatment 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) Open a glossary itemcan 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 Open a glossary item, 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

Trial design

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 (biopsy Open a glossary item) before starting treatment and after you finish your 1st treatment. They will use these samples to find out how well plerixafor is working.

Hospital visits

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 (ECG Open a glossary item)
  • Recording of the electrical activity of your heart (Holter test) Open a glossary item
  • 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.

Side effects

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
  • Dizziness
  • Headaches
  • 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.

Location

Cambridge

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Duncan Jodrell

Supported by

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12721

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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