Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of AZD2014 with paclitaxel for solid tumours (TAX-TORC)
This trial is looking at a drug called AZD2014 alongside paclitaxel. The people taking part have
More about this trial
AZD2014 is a type of biological therapy. It works by blocking the action of a protein called mTOR which helps to control how cells grow. Cells usually divide and grow in an orderly way. But in cancer cells, proteins such as mTOR can behave abnormally and the cells grow out of control. If mTOR is blocked, this may stop or slow the growth of the cancer.
The main aims of the trial are to
- Find the highest safe dose of AZD2014 you can have with paclitaxel
- Learn more about the side effects
- See what happens to the drug in the body
Who can enter
You may be able to enter the 1st part of the trial if you have a
You may be able to enter the 2nd part of the trial if you have ovarian cancer, fallopian tube cancer, primary peritoneal cancer or squamous cell lung cancer that has come back despite having other treatment.
And for both parts of the trial, you must
- Have cancer that can be measured
- Have satisfactory blood test results
- Be well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Be at least 18 years old
- Be willing to use reliable contraception if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain or spinal cord, or is putting pressure on your spinal cord (spinal cord compression)
- Have had chemotherapy, hormone therapy or
immunotherapyin the last 3 weeks (4 weeks if you had an experimental drug and 6 weeks if you had chemotherapy drugs called nitrosoureasor Mitomycin C) – you may be able to take part if you’ve been having paclitaxel (the trial team can advise you about this)
- Have had radiotherapy in the last 3 weeks unless it was to control symptoms (palliative radiotherapy)
- Have had radiotherapy that included more than a quarter of your
bone marrowin the last 8 weeks – your doctor can advise you about this
- Have had major surgery in the last 4 weeks or minor surgery in the last 2 weeks
- Haven’t recovered from the side effects of earlier treatment, unless they are very mild
- Have a blockage in your bowel (
- Have any problems with your
digestive systemthat could affect how you swallow or absorb the trial drug
- Are known to be very sensitive to paclitaxel or AZD2014 (or similar drugs)
- Have type 1 diabetes or type 2 diabetes that is not well controlled
- Take a drug called warfarin to thin your blood
- Take any drugs that can affect body substances called cytochrome P (CYP) enzymes – the trial team can advise you about this (it is important that you don’t stop taking any medication without speaking to your doctor)
- Have had a heart attack or stroke in the last year, have certain other heart problems or take other medication that can affect your heart – the trial team can advise you about this
- Have had a bone marrow transplant
- Have an infection that cannot be controlled, a lung condition called interstitial lung disease or serious problems with your liver or kidneys
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
- Have any other condition that the trial team think would affect your taking part in this trial
- Are taking part in another clinical trial of an experimental drug
- Are pregnant or breastfeeding
This phase 1 trial in 2 parts. In the 1st part of the trial, the researchers are trying to find the highest dose of AZD2014 that you can safely have alongside paclitaxel. People joining the first part of the trial can have any type of
Everybody taking part has paclitaxel through a drip into a vein once a week. AZD2014 comes as a tablet. Some people take tablets twice a day on 3 days each week. Some people take them twice on 2 consecutive days each week.
The first few patients taking part will have a low dose of AZD2014 on 3 days each week. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study. Once the researchers have found the highest safe dose you can have on 3 days a week, there will then be a dose escalation study to find the best dose to have on 2 days a week.
You have treatment for 6 weeks and then a week without any treatment. This 7 week period is called a cycle of treatment. If the treatment is helping, you can have up to 6 cycles, which takes about 9 months.
In the 2nd part of the trial, researchers want to learn more about the combination of AZD2014 and paclitaxel. The people joining this part of the trial will have ovarian cancer, fallopian tube cancer, primary peritoneal cancer or squamous cell lung cancer that has come back after having other treatment.
In this part of the trial, some people will have AZD2014 on 3 days each week. Some people with lung cancer may have it on 2 days a week. They will have the highest safe dose for each treatment plan that was found in the 1st part of the trial. Everybody will have paclitaxel once a week.
You see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood and urine tests
- CT scan or MRI scan
- Heart trace (
- Heart scan (
echocardiogram) or MUGA scan
The trial team will get a sample of your cancer that was removed when you had surgery or a
You go to hospital at least once a week to have treatment. You have regular blood tests and ECGs. You have another heart scan after the 1st cycle of treatment
The first few people taking part in the trial (the dose escalation study) have some extra blood tests in the first week of treatment. These are to see how much of each drug is in their blood and how the drugs affect the body. To have these extra tests, they stay in hospital overnight on 3 separate occasions.
If you agreed to have a biopsy before starting treatment, the researchers will ask you to have another one during the 1st cycle of treatment.
Everybody taking part has a CT or MRI scan at the end of each cycle of treatment.
When you finish treatment, you see the trial team again 4 weeks later. You have a physical examination, heart scan (ECG), blood tests and urine tests. You may have a CT or MRI scan if you haven’t had one recently.
As AZD2014 is a new drug, there may be some side effects we don’t know about yet. The possible side effects that researchers already know about include
- Tiredness (fatigue)
- Sore mouth
- Changes to the way your liver works
- Feeling or being sick
- Weight loss or loss of appetite
- A change in blood sugar levels making you very thirsty or pass urine more often – the trial doctors will monitor this carefully during the trial
- A drop in blood cells causing an increased risk of infection, tiredness and breathlessness
- An effect on your heart – the trial team will monitor this closely and it is important to let them know if you have chest pain, breathlessness or swollen ankles
We have more information about the side effects of paclitaxel.
You mustn’t eat certain foods during the trial as they can affect how AZD2014 works. This includes grapefruit and Seville oranges.
You mustn’t use sunbeds or tanning booths during the trial and for 3 months afterwards. If you go out in the sun during this time, you must wear sunglasses and use sunscreen.
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.
Dr Udai Banerji
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
This is Cancer Research UK trial number CRUKDE/12/013.