A trial of pazopanib for soft tissue sarcoma that has got worse during or after other treatment (PALETTE, EORTC 62072)

Please note this trial is no longer recruiting patients.

This trial is looking at a drug called pazopanib for soft tissue sarcoma that has spread (metastatic soft tissue sarcoma).

If soft tissue sarcoma spreads to somewhere else in the body, doctors may treat it with chemotherapy. But sometimes the sarcoma continues to grow or comes back after treatment and more chemotherapy may not help.

Pazopanib is a new drug that is a type of biological therapy called a tyrosine kinase inhibitor (MultiTKI). It works by blocking certain proteins called vascular endothelial growth factors (VEGFs). These are natural body chemicals that control cell growth. Blocking the growth factors may stop cancer growing.

This is the second trial of pazopanib for people with soft tissue sarcoma. The first one showed that pazopanib seemed to slow down or stop the growth in some people.

The aim of this trial is to see if pazopanib helps people with soft tissue sarcoma that has spread and has grown or come back despite other treatment.

Recruitment

Start 24/12/2008

End 01/03/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have soft tissue sarcoma that has spread from where it first started to somewhere else in the body and has come back or got bigger during or after treatment
Have already had at least one type of chemotherapy and it included the drug doxorubicin
Are well enough to take part in the trial (performance status 0 or 1)
Have satisfactory blood test results
Are able to swallow and absorb tablets
Are willing to use reliable contraception during the trial if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have any of the following types of sarcoma – liposarcoma, embryonal rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewings sarcoma or PNET, gastrointestinal stromal tumour, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma, or mixed mesodermal cancer of the womb (uterus)
Have sarcoma that has spread to your brain
Have had more than 4 other types of treatment for advanced sarcoma (if you had chemotherapy before or after your first surgery, you may still be able to take part)
Have had any other cancer drugs in the last 2 weeks
Have not yet recovered from the side effects of other cancer treatments unless they are very mild (apart from hair loss)
Have had an experimental drug as part of another clinical trial in the last 4 weeks
Have had any other cancer in the last 3 years apart from non melanoma skin cancer, carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
Have poor heart function (you will have a heart scan to assess this) or have had a heart attack, unstable angina, heart failure or treatment to unblock a vein (for example, angioplasty or a stent) in the last 6 months
Have ever had a stroke, or have had a blood clot in the last 6 months unless it has been controlled with blood thinning drugs and has been stable for at least 6 weeks
Have high blood pressure that cannot be controlled with medication
Have ever had surgery that could affect how well you absorb tablets from the stomach or bowel, or have had other problems with your digestive system (the trial doctors can advise you about this)
Have coughed up any blood in the last 6 weeks or have another bleeding problem
Have had major surgery in the last 4 weeks or have a wound, ulcer or broken bone that isn’t healing
Are known to be sensitive to drugs that are similar to pazopanib
Are pregnant or breastfeeding

Trial design

This trial will recruit 255 people in different countries. About 25 people will take part in the UK. It is a randomised trial. The people taking part will be put into one of 2 treatment groups by computer. Neither you nor your doctor can decide which group you are in. And neither you nor your doctor will know which group you are in. This is called a double blind trial.

People in group 1 have pazopanib tablets
People in group 2 have dummy tablets (placebo)

You take the tablets once a day, one hour before or 2 hours after a meal.

As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you.

You will be asked to fill out a questionnaire 5 times during the trial. The questionnaire will ask you abut any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You will see the trial doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Urine test
Heart trace (ECG)
Heart scan (Echocardiogram) or MUGA scan
Pregnancy test (if you are a woman who could possibly become pregnant)
CT scan or MRI scan

You go to see the trial team a week after you start taking the tablets and then every 4 weeks during the trial. At each visit you have blood and urine tests and you may have a heart scan or ECG. You have a CT or MRI scan every 4 weeks for the first 3 months and then every 8 weeks until your sarcoma gets worse or you start a different type of treatment.

When you finish treatment, you will go back to see the trial team within 4 weeks. After that, a member of the trial team may contact you by telephone to see how you are.

Side effects

As pazopanib is a new drug, there may be some side effects that we are not aware of yet. In trials so far, the side effects have included

Diarrhoea
Sickness
Pain or discomfort in the tummy (abdomen)
Tiredness (fatigue)
Taste changes
Lightening of hair or skin colour
Changes to the liver
Raised blood pressure
Headache
Rash
Blisters or rash on the palms of the hands or soles of the feet

There is more information about pazopanib on CancerHelp UK.

It is important that you don't eat grapefruit (or drink the juice) while you take pazopanib. And you must not take St John’s wort during the trial as it may interfere with how pazopanib works.