A trial of veliparib with chemotherapy for bowel cancer that has spread

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

Cancer type:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at veliparib alongside chemotherapy for bowel cancer that has spread to another part of the body (advanced bowel cancer). The trial is open to people who have not yet had treatment for their advanced bowel cancer.

More about this trial

Doctors can treat advanced bowel cancer with chemotherapy. One combination of chemotherapy drugs they use is called FOLFIRI. Sometimes doctors will also give a biological therapy called bevacizumab (Avastin) alongside FOLFIRI.

Researchers are always looking for ways to improve treatment and in this trial they are looking at a drug called veliparib.

Veliparib is a biological therapy called a PARP inhibitor. This means it blocks an enzyme Open a glossary item called PARP, which helps damaged cells repair themselves.

The cells in your cancer already have problems repairing damage. Doctors hope if they can also stop PARP working, the cancer cells will not be able to repair themselves and die.

In this trial half the people will have veliparib alongside FOLFIRI with or without bevacizumab. The other half will have a dummy drug (placebo Open a glossary item ) alongside FOLFIRI with or without bevacizumab.

The aim of this trial is to find out how well veliparib alongside FOLFIRI, with or without bevacizumab, works for bowel cancer that has spread.

Who can enter

You may be able to join this trial if all of the following apply. You

Have bowel cancer that has spread to another part of your body and you haven’t had treatment for the cancer spread
Have at least 1 area of cancer that can be seen on a scan but can’t be removed by surgery
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 3 months afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot join this trial if any of these apply. You

Have already had treatment for your bowel cancer spread
Had chemotherapy as a part of your initial treatment for bowel cancer and your cancer came back within a year of your last dose of chemotherapy
Have had radiotherapy to more than a quarter of your bone marrow (your doctor can tell you this)
Have had radiotherapy in the past 4 weeks
Have had major surgery in the past 4 weeks
Have had an experimental drug as part of a clinical trial in the past 28 days
Have had another cancer in the past 3 years apart from some early cancers that have been successfully treated
Have diarrhoea that isn’t controlled with medication
Have had a blockage in the bowel (bowel obstruction) or a tear in your bowel tissue (perforation) in the past 28 days
Have certain heart problems (the trial team can advise you about this)
Have sickness that isn’t controlled with medication
Have an infection
Have a condition in which there is a build up of pigment called bilirubin making your skin or the whites of your eyes yellow (Gilbert’s syndrome)
Have any other medical or mental health problem that the trial team thinks could affect you taking part in this trial
Are allergic to any of the drugs used in this trial
Are pregnant or breastfeeding

You may not have bevacizumab as part of your treatment if any of the following apply. You

Have cancer spread to your brain or spinal cord
Have had a major bleed in the past 6 months
Have high blood pressure that isn't controlled by medication
Have had a tear in the tissue (perforation) of your digestive system in the past year
Have had a blood clot in the past 2 months
Have a wound that won’t heal
Have an ulcer or broken bone (fracture)
Have already had bevacizumab
Are allergic to bevacizumab or any of its ingredients

Trial design

This is an international phase 2 trial. The researchers need 120 people worldwide to join.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And you will not know which group you are in. This is called a double blind trial.

People in one group have veliparib and FOLFIRI with or without bevacizumab
People in the other group have a dummy drug (placebo) and FOLFIRI with or without bevacizumab

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Your doctor will talk to you about having bevacizumab if they feel you will benefit from having it.

Veliparib and the dummy drug are capsules. You take them twice a day for 1 week out of every 2 weeks. Each 2 week period is called a cycle of treatment.

As long as the side effects aren’t bad and it is still helping, you can continue treatment with veliparib or the dummy drug until the end of the trial.

FOLFIRI is a combination of irinotecan and folic acid. You have these drugs through a drip in a vein. If you are having bevacizumab, you have it through a drip in a vein at the same time.

You have the 5FU as an injection through a drip into a vein, when you have the other drugs. If you are in the group having veliparib, you won’t have this dose of 5FU. You have a mixture of salt in water (saline) instead.

Everyone has continuous 5FU over 46 hours. You have the 5FU through a small pump you take home. When the 5FU is finished you need to go back to the hospital to have it disconnected.

You have these drugs every 2 weeks. Each 2 week period is called a cycle of treatment. You can have FOLFIRI with or without bevacizumab as long as it helping you.

If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had a biopsy Open a glossary item and some extra blood samples. They will use these to look for substances (biomarkers ) in the samples that my show how the treatment is working.

The trial team are also doing a mini (sub) study looking at how your genes Open a glossary item affect how well veliparib works and to find out more about bowel cancer. To do this they will ask for an extra blood sample to be taken along with your routine bloods. You don’t have to agree to this if you don’t want to. You can still take part in the main trial.

Hospital visits

You see the doctor to have some tests before you take part in the trial. These tests include

A physical examination
Blood tests
Heart trace (ECG )
Urine test
CT scan or MRI scan

During treatment you see the trial doctor regularly for a physical examination and blood tests. You have a CT scan or MRI scan every 8 weeks.

When you finish treatment you see the doctor for the same tests you had at the start. You then see the doctor every month for a year, then every 2 months for 2 years.

Side effects

The most common side effects of veliparib are

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Feeling or being sick
Diarrhoea or constipation
Loss of appetite
Stomach pain
A change to the way your liver works
Headache
Feeling dizzy
An increase in the levels of sugar in your blood
Problems sleeping
A decrease in the levels of sodium in your blood
Changes to taste