A phase 1 trial looking at the drug Plerixafor for treating people with advanced (metastatic) pancreatic, ovarian and bowel cancer (CAM-PLEX)
Full title: To assess the safety of continuous IV administration of the CXCR4 antagonist, plerixafor (Mozobil), at potentially active plasma concentrations and assess its impact on the immune microenvironment in patients with advanced pancreatic, high-grade serous ovarian and colorectal adenocarcinomas (CAM-PLEX)
Why is this trial being carried out?
Pancreatic cancer that has spread to other parts of the body is called advanced or metastatic pancreatic cancer. People with advanced pancreatic cancer are usually offered chemotherapy. In this early phase research trial researchers are looking at a new way of treating cancer called immunotherapy. Immunotherapy works by using the body’s own immune system to fight the cancer.
Plerixafor is a drug that is currently used to treat people with myeloma and non Hodgkin lymphoma. Both of these cancers affect the body’s immune system.
Recent laboratory studies have shown that a drug called plerixafor may be used to help the body’s own immune cells to attack the cancer cells. In this trial, researchers want to see if this immunotherapy drug may work for people with advanced pancreatic, ovarian or bowel cancer. The CAM-PLEX trial will also aim to find out what is the highest and safest dose of plerixafor to give.
If you take part in this trial, you will have blood and cancer tissue samples taken before and after you have plerixafor. Researchers will then use these samples to find out how well plerixafor is working.
During the trial you will also have your cancer monitored using scans to give a clearer picture of the cancer. Positron emission tomography (PET) scans produce images of the inside ofwithin the body, using a small amount of a radioactive-labelled agent fluorodeoxyglucose (FDG). This is combined with computerised tomography (CT) scans to produce more detailed images of the cancer and the surrounding organs to show the differences between healthy and cancerous tissues.
Who is the trial suitable for?
The CAM-PLEX trial may be suitable for you if you:
- have pancreatic, ovarian or bowel cancer called adenocarcinoma that has spread to another part of the body and cannot be removed by surgery
- have had standard chemotherapy treatment to treat your cancer which has stopped working, or have decided not to have chemotherapy
- have cancer that it is possible to take a biopsy from
- have satisfactory blood tests – your trial team will discuss this with you
- are well enough to do normal daily activities.
It is not suitable for you if you:
- are allergic to plerixafor
- have had chemotherapy in the past 28 days
- have taken steroids or any medication that can affect their immune system in the past 28 days
- have an active infection – the trial team will discuss this with you
- have certain heart problems – the trial team will talk to you about this
- have HIV, hepatitis B or hepatitis C
- are taking part in another clinical trial using drug treatment.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you.
Recruitment start date: June 2015
Recruitment end date: March 2018
Published April 2016
Review date June 2017
The CAM-PLEX trial is being carried out in:
Addenbrooke’s Hospital, Cambridge
Prof Duncan Jodrell
You can contact the trial centre:
Mrs Lisa Bax, Addenbrooke’s Hospital, Cambridge Cancer Trials Centre
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial please visit the ClinicalTrials.gov website.
For information used to develop this information please email us.