"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at personalised therapy for people with cancer of unknown primary
In this trial doctors want to find out whether personalised therapy is better than chemotherapy for people with cancer of unknown primary (CUP).
Personalised therapy involves using information about your cancer
More about this trial
Cancer of unknown primary (CUP) means that cancer spread has been found in your body, but your doctors can’t find where the cancer started (the primary cancer).
Chemotherapy is a common treatment for CUP. It uses anti cancer (cytotoxic) drugs to destroy cancer cells. Common chemotherapy treatments include:
Researchers are looking at new ways to treat cancer. An area that they are looking at is personalised therapy.
Cancer cells have changes in their genes (
A technique called genomic profiling can scan the genes of the cancer and identify those changes. Doctors hope they can match a treatment to your individual cancer.
Everyone taking part in this trial has treatment in 5 parts (stages):
- stage 1 is screening to work out if you can take part
- stage 2 is the induction period (everyone has treatment with chemotherapy)
- stage 3 is the end of induction assessment
- stage 4 is the treatment period (everyone has either more chemotherapy or personalised therapy)
- stage 5 is the follow up
The main aim of this trial is to find out whether personalised therapy is better than chemotherapy for people with CUP.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have cancer that has spread to other parts of the body and doctors don’t know where the cancer started (cancer of unknown primary)
- can’t have surgery or radiotherapy to cure your cancer
- have at least 1 area of cancer that can be seen and measured on a scan
- are willing to have a sample of tissue taken (biopsy) if there isn’t a suitable sample taken in the past 3 months
- are willing to have a blood test to look at your genes (genomic profile)
- can have treatment with a platinum chemotherapy such as cisplatin or carboplatin
- have satisfactory blood tests results
- are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
- are willing to use reliable contraception during treatment and for up to 2 years afterwards if there is any possibility that you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply.
- have CUP that started in certain cells such as
squamous cells(your doctor can tell you more about this)
- have cancer spread in the brain,
spinal cordor the membranes that surround the brain (carcinomatous meningitis)
- have had treatment for CUP, unless it was surgery or radiotherapy
- have had another cancer in the last 5 years apart from
carcinoma in situof the cervix, non melanoma skin canceror stage 1 womb cancer
- have high levels of calcium (hypercalcaemia) that is causing symptoms
- have liver problems such as hepatitis or
- have heart problems such as angina that isn’t controlled, an irregular heart beat (arrhythmia) or you have had a heart attack in the last 3 months
- have had a major surgery in the last month, unless it was an operation to diagnose your cancer
- have had an organ transplant or stem cell transplant from a donor
- have had an investigational treatment in the past month
- have HIV
- have hepatitis B or hepatitis C
- have active tuberculosis (TB)
- drink an amount of alcohol that is a concern for your doctor
- have any other medical condition that the trial team think could affect you taking part
- are sensitive to any of the drugs used in this trial
- are pregnant or breastfeeding
As well as the above, there are other entry conditions that will affect whether you can join the personalised therapy part of this trial (stage 4). It depends on the treatment your doctor thinks is best for you. Your doctor can tell you more about all the entry conditions that applies to you.
This is an international phase 2 trial. Researchers hope that around 790 people worldwide and 76 people from the UK will take part.
This trial is in 5 parts (stages):
Stage 1 (screening)
You have tests such as blood tests and a CT scan to see whether you can take part in this trial.
The trial team ask to use a sample of your cancer (archival tumour sample) taken in the past 3 months. You need to have a
Doctors want to confirm your diagnosis and look for changes in the genes (the genomic profile). You also have a blood test to look for gene changes.
You join the 2nd stage of this trial if your doctor thinks you are well enough and that all the entry criteria apply to you. Your doctor will tell you which other treatments you might have if you can’t join the 2nd stage of this trial.
Stage 2 (induction)
Your doctor can tell you which chemotherapy treatment you will have. It can be 1 of the following:
- cisplatin and gemcitabine
- carboplatin and gemcitabine
- carboplatin and paclitaxel
Stage 3 (end of induction assessment)
You have a CT scan to see how well the induction treatment worked.
You also have more tests such as blood tests to see whether you are well enough to join stage 4 (treatment).
Stage 4 (treatment)
The treatment you have depends on how well the induction treatment worked.
If your cancer stayed the same or got better after induction treatment, you are put into 1 of the following treatment groups by a computer:
- personalised therapy that is chosen by your doctor depending on your genomic profile
Neither you nor your doctor can choose which group you are in. And you are 3 times more likely to have personalised therapy than chemotherapy.
If your cancer got worse after induction treatment, it means the chemotherapy didn’t work and you will have the personalised therapy.
Your doctor can tell you which personalised therapy you have. It can be:
- erlotinib and bevacizumab
- vemurafenib and cobimetinib
- trastuzumab, pertuzumab and chemotherapy
- atezolizumab and chemotherapy
If you have chemotherapy, you have the same drugs you had during the 2nd stage of this trial (induction).
Stage 5 (follow up)
After treatment, you see or speak with the trial doctor every 3 months, for about 5 years. This is to check how you are.
You see a doctor and have some tests before starting treatment. The tests might include:
During treatment, you see the trial team regularly. You have blood tests, physical examinations and other tests depending on which treatment you have.
You have a CT scan or MRI scan every 9 weeks during the treatment stage. This continues for as long as the treatment is helping you and the side effects aren’t too bad.
After you finish treatment, you continue to see or speak with the trial team every 3 months. This is the follow up. You have follow up for up to 5 years after you finish treatment.
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. You have different treatments as part of this trial, and each treatment has possible side effects.
The team will tell you about all the possible side effects for your specific treatment before you start the trial.
Below are some of the possible side effects of cancer drugs. This is not a complete list of all the most common side effects of all drugs used in this trial:
- a drop in the number of blood cells causing an increased risk of bleeding, infection and breathlessness
- tiredness (fatigue)
- feeling or being sick
- mouth sores and ulcers
- problems with your kidneys and liver
- lung problems such as cough
- skin problems such as skin rash and itching
- diarrhoea or constipation
- allergic reaction
- numbness or tingling in fingers and toes
- difficulty swallowing
- fever (high temperature)
- hair loss
- muscle and joint pain
- flu like symptoms
We have information about the possible side effects of:
How to join a clinical trial
Dr Kai Keen Shiu
F. Hoffmann-La Roche Ltd