A trial of RO5083945 for bowel cancer that has spread to another part of the body

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 a new drug called RO5083945 alongside FOLFIRI chemotherapy for bowel cancer. The trial is for people who have bowel cancer that has spread to another part of the body and has got worse despite having 1 previous type of chemotherapy.

If bowel cancer spreads to another part of the body, it is called advanced bowel cancer or metastatic bowel cancer. Doctors often treat metastatic bowel cancer with chemotherapy. But the cancer may start to grow again and researchers are looking for new treatments. In this trial they are looking at a new drug called RO5083945 which is a type of biological therapy called a monoclonal antibody.

RO5083945 may be able to stop or slow down the growth of bowel cancer cells. And it may also help the immune system to attack the cancer cells.

Everybody taking part will have FOLFIRI chemotherapy. This is a combination of 3 drugs called irinotecan, fluorouracil and folinic acid. Some people will also have RO5083945 and some will have another monoclonal antibody called cetuximab.

We know from recent research that cetuximab doesn't help people whose cancer has a change (mutation Open a glossary item) to a gene called K-RAS. So the researchers will test for this. You will not be involved in the part of the trial comparing RO5083945 with cetuximab if tests show that your bowel cancer cells have a K-RAS gene mutation. But you will have either RO5083945 and FOLFIRI or FOLFIRI alone.

Some cancer cells have receptors called epidermal growth factor receptors (EGFR) on their surface. A protein produced naturally in the body called epidermal growth factor (EGF) attaches to the receptors. This triggers the cell to grow and divide into more cells. Cetuximab and RO5083945 work by blocking the EGF receptors. This prevents the EGF protein reaching the cancer cells and stops them from growing.

The aims of the trial are to see

  • If RO5083945 and FOLFIRI chemotherapy works better than cetuximab and FOLFIRI for bowel cancer with a normal K-RAS gene
  • If RO5083945 and FOLFIRI works better than FOLFIRI alone for bowel cancer with K-RAS gene mutation

They also want to learn more about the side effects of RO5083945 and to compare a new tumour biopsy Open a glossary item with a stored sample that was taken when you were first diagnosed with cancer to look at how many EGF receptors there are.

Who can enter

You may be able to enter this trial if you

  • Have cancer of the large bowel (colon) or back passage (rectum)
  • Have already had 1 type of chemotherapy for advanced bowel cancer that included the drug oxaliplatin, and your cancer got worse during this treatment or within the next 6 months
  • 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 the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old
  • Are willing to have a new tumour biopsy when you join the study

You cannot enter this trial if you

  • Have cancer that has spread to your brain or spinal cord
  • Have already had irinotecan
  • Have already had a monoclonal antibody or another drug that targets EGF receptors
  • Have had radiotherapy in the last 4 weeks apart from radiotherapy to treat pain caused by cancer that has spread to your bones
  • Have taken part in another clinical trial or had another experimental drug in the last 4 weeks
  • Have a condition affecting your liver called Gilbert’s syndrome
  • Are known to be very sensitive to any of the drugs being used in the trial
  • Take steroids Open a glossary item on a long term basis (it is important that you don’t stop taking steroids without talking to your doctor first)
  • Have an autoimmune disease Open a glossary item such as ulcerative colitis
  • Have had major surgery or a serious injury in the last 4 weeks
  • Have any other condition that the trial doctors think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit about 160 people. People who have a normal K-ras gene will be in treatment arm A. People who have a K-RAS gene mutation will be in treatment arm B.

Within each treatment arm, people are put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called randomisation.

In treatment arm A

  • People in group 1 have RO5083945 and FOLFIRI chemotherapy
  • People in group 2 have cetuximab and FOLFIRI

In treatment arm B

  • People in group 3 have RO5083945 and FOLFIRI
  • People in group 4 have FOLFIRI alone

The first cycle of treatment is 3 weeks long. Following this, you have 2 week cycles of treatment

People in groups 1 and 3 have

  • RO5083945 in the first week of treatment cycle 1
  • RO5083945 and FOLFIRI chemotherapy in the second week
  • No treatment in the third week
  • Then from cycle 2 onwards, RO5083945 and FOLFIRI in the first week and no treatment in the second week

People in group 2 have

  • Cetuximab every week in treatment cycle 1
  • FOLFIRI chemotherapy in the second week
  • Then from cycle 2 onwards, cetuximab and FOLFIRI in the first week and cetuximab alone in the second week

People in group 4 have

FOLFIRI in the second week of treatment cycle 1

  • No treatment in the first or third week
  • Then from cycle 2 onwards, FOLFIRI in the first week and no treatment in the second week

You have treatment through a drip into a vein. The study team will explain how long it will take to have the different types of treatment.

As long as you don’t have bad side effects you can carry on having treatment for as long as it helps you. If you have chemotherapy side effects, you may stop having chemotherapy (or parts of the chemotherapy combination) after a few treatment cycles, but carry on having cetuximab or RO5083945 on its own. Or if you have side effecs related to cetuximab or RO5083945, you may stop having cetuximab or RO5083945 but carry on with chemotherapy.

You will be asked to complete a questionnaire after 3 weeks of treatment, 4 weeks later and then every 8 weeks after that. The questionnaire will ask if you have had a skin rash from taking the drugs and how this affected your quality of life Open a glossary item.

Hospital visits

Before you can join this trial, the researchers must check to see if you have a K-RAS gene mutation. They also need to check how many EGF receptors there are on the cancer cells. So you will need to have a biopsy Open a glossary item of your cancer.

You will have some other tests before you start treatment. These include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood and urine tests
  • CT scan or MRI scan

How often you go to hospital for treatment will depend on which group you are in. You have regular blood tests.

You have an ECG and a CT or MRI scan every 8 weeks during treatment. The researchers may ask you to have another biopsy after about 3 weeks of treatment.

When you finish having treatment, you see the trial team about 4 weeks later. If your cancer has got worse, they will ask you if they can contact you in the future to see how you are.

If your cancer has not got any worse, they will ask you to carry on having scans every 8 weeks until your cancer starts to grow again, or until the trial has completely finished.

Side effects

As RO5083945 is a new drug, there may be some side effects we don’t know about yet.

It is possible you may have a reaction to the drug causing flu like symptoms such as a fever, chills and shivering, a headache, feeling or being sick, changes to your blood pressure and breathing difficulties. You have other medication beforehand to try to prevent a reaction and the trial team will monitor you very closely when you have the drug. If you have any problems, they will stop the drip for a while and treat any symptoms you have.

Other possible side effects of RO5083945 include

  • Skin rash
  • A drop in the level of magnesium in your blood
  • Dry or itchy skin
  • Tiredness (fatigue)

There is more information about the side effects of cetuximab and FOLFIRI chemotherapy on CancerHelp UK.

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.

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

Chief Investigator

Professor Cunningham

Supported by

Experimental Cancer Medicine Centre (ECMC)
F. Hoffmann - La Roche
Limited

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 7660

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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