A trial comparing gemcitabine and vandetanib with gemcitabine alone in pancreatic cancer (ViP)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Pancreatic cancer

Status:

Closed

Phase:

Phase 2

This trial is comparing gemcitabine and vandetanib to gemcitabine alone for people with pancreatic cancer. This trial is supported by Cancer Research UK.

Doctors usually treat pancreatic cancer with gemcitabine if it cannot be removed with surgery.

Pancreatic cancer is very difficult to treat. Even if it has not spread anywhere else in the body, surgery to remove pancreatic cancer may not be possible. Researchers are looking for new ways of treating pancreatic cancer that cannot be removed with surgery.

In this trial they want to use a new drug vandetanib with gemcitabine.

Vandetanib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short).

Tyrosine kinase is a chemical messenger (an enzyme) that sends messages to cells telling them to grow and divide. Blocking the effect of tyrosine kinase may stop cancer cells from growing and spreading.

The aims of this trial are

To find out if gemcitabine and vandetanib are better at treating pancreatic cancer than gemcitabine alone
To find out more about the side effects

Who can enter

You may be able to enter this trial if you

Have cancer of the pancreas that cannot be removed
Have cancer of the pancreas that has come back after surgery
Have cancer that can be measured on a CT scan
Are well enough to be up and about for at least half the day (performance status 0,1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception during the trial and for 1 year after if there is any chance that you or your partner could become pregnant
Are aged 18 years or more

You cannot enter this trial if you

Have cancer that has spread to your brain
Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 5 years ago
Have had chemotherapy for pancreatic cancer in the last 12 months
Have had major surgery in the last 4 weeks
Have a wound that has not healed
Have any other illness that could interfere with the results of the trial
Have a severe heart condition
Have an irregular heart beat that cannot be controlled with medication
Have an abnormal heart trace (ECG )
Have high blood pressure that cannot be controlled with tablets
Have diarrhoea that may affect your ability to absorb the vandetanib
Are unable to absorb tablets for any reason
Have had radiotherapy in the last 4 weeks
Are taking certain drugs for example St John’s Wort, phenytoin, carbamazepine, rifampicin, rifabutin and phenobarbital
Are pregnant or breastfeeding

Trial design

This trial will recruit 140 people in the UK. This is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in either. This is called a ‘blind’ trial.

Group A have gemcitabine and a dummy drug (placebo )
Group B have gemcitabine and vandetanib

Everybody taking part has gemcitabine through a drip into a vein once a week for 7 weeks. Then a week with no gemcitabine.

After the first 8 weeks you now have gemcitabine once a week for 3 weeks followed by a week off. Each 4 week period is called a cycle.

Each treatment takes about 30 minutes.

People in group A take placebo tablets and people in group B take vandetanib tablets every day, even during the week they are not having gemcitabine.

You have gemcitabine and vandetanib or placebo for as long as the treatment is working.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. If there is no tissue available from your original surgery the researchers may ask if they can take another biopsy Open a glossary item of your cancer.

The researchers will also ask you for some extra blood samples.

The tissue and blood samples will be used to find out more about pancreatic cancer and its treatment in the future.

If you don’t want to give tissue or blood samples for this study, you do not have to. You can still take part in the trial.

Hospital visits

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

Physical examination
Blood tests
Heart trace (ECG )
CT scan
Pregnancy test

You will have more heart traces (ECGs) recorded during the first 12 weeks of the trial.

Each time you have gemcitabine you have a blood test and you will be asked about any pain you have been having.

Every 4 weeks you have a physical examination.

You have a CT scan every 3 months until the cancer starts to grow.

You will continue on the trial until your cancer starts to grow or you no longer want to be in the trial.

7 days after you finish the trial treatment you will see the doctors. You then see them every 3 months in clinic or they can ring you at home.

Side effects

The most common side effects of gemcitabine are

Feeling or being sick
Abnormal blood test results
A drop in blood cells
Skin rash which may itch

The most common side effects of vandatanib are

Feeling or being sick
Constipation
Diarrhoea
Tiredness (fatigue)
An increase in your blood pressure
Not wanting to eat (anorexia)
Difficulty sleeping

We have more information about gemcitabine.

Recruitment start:

10/10/2011

Recruitment end:

23/10/2013

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.

Print page

Email this page

Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Gary Middleton

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Liverpool Cancer Trials Unit
NIHR Clinical Research Network: Cancer
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool