Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial comparing 2 ways of taking sunitinib or pazopanib for advanced kidney cancer (STAR)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Kidney cancer
Renal cell cancer
Status:
Closed
Phase:
Phase 2/3
This trial is comparing taking sunitinib (also known as Sutent) or pazopanib (also known as Votrient) continuously with having planned treatment breaks. It is for people with advanced kidney cancer.
More about this trial
The most common type of kidney cancer in adults is renal cell cancer. When it cannot be removed with surgery, or has spread to another part of the body, doctors can treat it with either a drug called sunitinib or pazopanib. You would usually continue taking either sunitinib or pazopanib until it no longer controls the cancer or you become unable to manage the side effects for any reason.
Sunitinib and pazopanib are both a type of biological therapy called a tyrosine kinase inhibitor. And like all drugs sunitinib and pazopanib have side effects.
We know from research that for some cancers, the side effects of drugs may be reduced by stopping and starting the treatment, without affecting how well the drug works. This is called a planned treatment break.
The researchers want to compare giving continuous sunitinib or pazopanib with planned treatment breaks for people with advanced kidney cancer.
Who can enter
You may be able to enter this trial if you
- Have the most common type of kidney cancer called renal cell cancer
- Have locally advanced cancer that can’t be removed with surgery or your kidney cancer has spread to another part of your body (metastatic)
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for 6 months after if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
If you took part in the SORCE trial you may be able to join this trial if your doctor knows you were taking the dummy drug (placebo).
You cannot enter this trial if you
- Have cancer that has spread to the brain – you may be able to join if the cancer in your brain has been removed completely with surgery or is being treated with stereotactic brain radiotherapy or radiosurgery
- Have already had sunitinib, pazopanib or a similar drug
- Have high blood pressure that is not well controlled
- Have lung, or central chest disease that is causing a blockage or bleeding
- Are coughing up blood
- Have, or have had, another cancer apart from non melanoma skin cancer or superficial bladder cancer
- Are sensitive to sunitinib or pazopanib
- Are taking medication that could affect the way sunitinib or pazopanib works in the body
- Have any other medical condition that could affect you taking part in this trial
Trial design
This is a phase 2/3 trial. Initially the trial aimed to recruit about 210 people in the phase 2 stage. This phase was completed in summer of 2014 and now the trial will continue in to the phase 3 stage and recruit a total of 920 people.
Everyone in this trial will take either sunitinib or pazopanib. Your doctor will talk to you about which one is best for you.
It is a randomised trial. You are put in to 1 of 2 groups. Neither you nor your doctor can choose which group you are in.
In group 1, if you are having sunitinib you take it for 4 weeks and then have 2 weeks of not taking it. This is the standard way of taking sunitinib. Each 6 week period is called a cycle of treatment. If you are having pazopanib you take it every day. This is the standard way of taking pazopanib. You continue taking sunitinib or pazopanib as long as you don’t have any bad side effects and it is still helping you.
In group 2, you take sunitinib or pazopanib the same as people in group 1. You take it for 4 cycles. You then stop taking sunitinib or pazopanib. This is called a planned treatment break. During the planned treatment break you will see the doctor and have scans regularly as if you were still taking sunitinib or pazopanib. You start taking sunitinib or pazopanib when your cancer starts to grow again. If your cancer is still controlled and after you have had at least another 4 cycles you may have another treatment break if your doctor thinks it is suitable for you. You continue having sunitinib or pazopanib this way until it no longer controls your cancer while you are taking it or you develop bad side effects.
You will fill in a questionnaire before starting treatment, then every 6 weeks. At week 24 the researchers give you a pack of questionnaires to fill in at home. You fill them in every 2 weeks for 6 weeks. This is called a quality of life study.
Hospital visits
You see the doctor before starting treatment to have some tests. These may include
During treatment and any planned treatment breaks you see the doctor every 6 weeks for a physical examination and blood tests. Every 12 weeks you have a CT scan or MRI scan.
After treatment your doctor will tell you how often they would like to see you.
Side effects
The most common side effects of sunitinib can include
- Loss of hair colour
- Puffy, watery eyes
- Sore mouth, ulcers
- Changes in taste
- Skin problems
- Indigestion
- Heart problems
- Feeling or being sick
- Diarrhoea
- High blood pressure
- A change to the way your
thyroid 
works
The most common side effects of pazopanib can include
- Loss of hair colour
- Sore mouth, ulcers
- Changes in taste
- Skin problems
- Indigestion
- Heart problems
- Feeling or being sick
- Diarrhoea
- High blood pressure
- A change to the way your thyroid works
We have more information on sunitinib and pazopanib in our cancer drugs section.
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
Dr Janet Brown
Supported by
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University of Leeds
Freephone 0808 800 4040
Last review date
CRUK internal database number:
8740
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
