A study to see how PET scans pick up blood supply changes to ovarian cancer treated with pazopanib and paclitaxel (PAZPET 1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is using PET scans to see how well the drugs pazopanib and paclitaxel stop abnormal 
growing in ovarian cancer that has continued to grow despite having .
Cancers need a blood supply to help them grow and survive. So growing cancers encourage the growth of new blood vessels. This is called angiogenesis. Pazopanib is a drug that mainly targets blood vessels supplying a cancer. Paclitaxel is a type of chemotherapy that both shrinks cancers and also targets abnormal blood vessels.
Researchers in this study are looking at these 2 drugs together, to see how they affect ovarian cancer that has continued to grow despite having platinum chemotherapy. They will use PET scans to look at changes in the cancer’s blood vessels during and after treatment. They will also look at the size of your cancer before, during and after chemotherapy. And compare cancer tissue samples to what they see on the PET scans. The aims of this study are to see
- How well PET scans show how pazopanib is working
- How safe the combination of pazopanib and paclitaxel is, and how well it works
- Whether they can link what happens to pazopanib in the body with how well it works and how it affects your body
Who can enter
You may be able to enter this study if you
- Have ovarian cancer that did not respond to platinum chemotherapy (such as carboplatin or cisplatin) when you were originally treated, or your cancer came back within 6 months of having this treatment
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have cancer that can easily be measured on a scan – you can check this with your doctor
- Have satisfactory blood tests
- Are willing to use reliable contraception if there is any chance that you could become pregnant during the study
- Are at least 18 years of age
You cannot enter this study if you have
- High blood pressure (upper reading above 140, or lower above 90) – you can check this with your doctor
- A build up of fluid in your tummy area because of your cancer (ascites)
- Moderate to severe numbness and tingling in your hands or feet (peripheral neuropathy)
- Had radiotherapy in the last 28 days
- Had surgery or treatment to cut off the blood supply to your cancer (
embolisation ) in the last 14 days - Had chemotherapy,
immunotherapy , biological therapy, hormone therapy or any treatment as part of a clinical trial in the last 2 weeks, or longer ago than this if the drug could still be in your system – you can check this with your doctor - Had any treatment with drugs that block blood vessel growth (anti angiogenics)
Trial design
This study will recruit 17 women. Everyone taking part will have pazopanib and paclitaxel, and some tests and scans for the study.
Before you start your treatment you have a biopsy guided by ultrasound, under . You also have a PET scan. For the scan, the staff will put a fine needle into a vein in your arm. This is to inject the tracer for the scan, and take the study blood samples.
You then start your course of treatment by taking pazopanib tablets every morning throughout the study. One week after you start, you have another PET scan. You then have paclitaxel through a drip into a vein. You have paclitaxel weekly after this, for 18 weeks. You keep taking pazopanib throughout, and after you finish the course of paclitaxel, until it is no longer helping your cancer.
You have regular blood and urine tests and throughout the study, as well as a couple of CT scans during treatment, which the team will compare with the PET scan pictures.
If your cancer comes back again, you stop taking pazopanib and have another PET scan, blood test and a biopsy guided by ultrasound. You finish the study at this point and discuss further treatment with your regular specialist.
Hospital visits
Before you start the study, you see the doctor and have a blood and urine test and a heart trace (ECG).
You come to the hospital every week for your paclitaxel chemotherapy. After you finish the 18 week course of paclitaxel chemotherapy and you are just taking pazopanib, you come to the hospital every 8 weeks.
You come to hospital to have your study biopsy or biopsies. You will need to have up to 4 hours bed rest at the hospital after your biopsy, but you should be able to go home the same day.
Each PET scan will take about 65 minutes. The study team will pay for a taxi to take you and a friend or relative to and from the PET scans. They will also pay your travel expenses as needed.
Side effects
Complications of biopsies are rare but may include
- Bleeding
- Infection
- Pain
- Possible damage to organs next to where the biopsy was taken
You may have mild bruising from the needle into your arm during your PET scan. This should go within a couple of weeks.
You will be exposed to some extra radiation as a result of taking part in this study. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The amount of extra radiation you would have from the PET scans in this study is about the same as 13 years of background radiation. The team think that this is not likely to cause you any harm.
Side effects of taking pazopanib with paclitaxel may include
- Feeling and being sick
- Tiredness
- Diarrhoea
- Loss of appetite
- Changes to the way your liver works
- Possible effects on your heart rhythm
- Problems with blood clotting and bleeding
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.
Chief Investigator
Dr Rohini Sharma
Supported by
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
Imperial College London
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
