A trial of pazopanib before surgery for kidney cancer - PANTHER

This trial is looking at pazopanib before surgery for kidney cancer that has spread to another part of the body.

The most common type of kidney cancer is renal cell cancer. There are several different types of renal cell cancer. The most common is called clear cell cancer.

If the cancer has spread outside your kidney, you may have an operation to remove your kidney (a nephrectomy). You may then have treatment with a biological therapy.

Pazopanib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short). TKIs block tyrosine kinase, which is a chemical messenger that sends messages telling cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

In this trial, researchers want to find out if there is a benefit to starting pazopanib before surgery.

The aims of the trial are to find out

If having pazopanib before surgery to remove your kidney helps people with kidney cancer that has spread to another part of the body
What the complications of surgery could be after having pazopanib

Recruitment

Start 06/07/2010

End 31/08/2012

Phase

Phase 2

Who can enter

You may be able to enter this trial if you

Have clear cell cancer that has spread to another part of the body
Have satisfactory blood test results
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Are willing to use reliable contraception during treatment and for 3 months after if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have already had treatment for kidney cancer that reaches your whole body (systemic treatment)– you may join the trial if you had radiotherapy to relieve symptoms of your kidney cancer
Have already had surgery to remove your kidney
Have had a heart attack or stroke in the last 6 months
Have a serious heart problem such as heart failure or heart pain (angina) that needs treatment
Have a problem with your heart rhythm that is not controlled with medication
Have high blood pressure that is not controlled with medication
Have problems with your digestive system such as ulcerative colitis, peptic ulcer or inflammatory bowel disease, or anything else that could affect the way you absorb tablets
Have a bleeding problem
Have had another cancer in the last 5 years that needed treatment apart from prostate cancer that was only in the prostate gland (localised) and did not need treating with hormone therapy
Have another medical condition that could affect you taking part in this trial

Trial design

This is a phase 2 trial. It will recruit about 95 people from around the UK.

Everyone taking part will have pazopanib. It is a tablet you take once a day. You take pazopanib for 12 to16 weeks before surgery to remove your kidney. You stop taking it 2 days before surgery and start taking it again at least 2 weeks after surgery.

If you are not well enough to have surgery after 14 weeks of pazopanib, you can continue taking it as long as your doctor feels it is helping you.

Whether or not you have surgery, you can continue having pazopanib as long as you don’t have bad side effects and it is still helping you.

Hospital visits

You will see the doctor and have some tests before having treatment. These tests include

A physical examination
Blood tests
CT scan and possibly MRI scan and PET scan
Heart trace – ECG
Ultrasound of the heart – ECHO (if needed)

You see the doctor after 4 weeks of treatment to see how you are and to check if you are having any side effects.

At 8 and 12 weeks you see the doctor for blood tests. You also have a heart trace (ECG) at week 12.

Before surgery you see the doctor for a physical examination and blood tests.

Two weeks after surgery you see the doctor for a physical examination and blood tests before you start taking pazopanib again.

You see the doctor at 4 and 6 weeks after restarting the treatment and have blood tests. At 6 weeks you have a CT scan.

After surgery you see the doctor every 6 weeks while having pazopanib. If you agree the trial team will then contact you every 4 months to see how you are.