A trial of additional treatment for oesophageal cancer and stomach cancer (PLATFORM)

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Cancer type:

Oesophageal cancer
Stomach cancer

Status:

Open

Phase:

Phase 2

This trial is looking at giving more treatment after first treatment for oesophageal cancer and stomach cancer that can’t be removed by surgery. It is open to people with

And the cancer has spread into the nearby tissue or to another part of the body.

More about this trial

Doctors use chemotherapy to treat these cancers. If your cancer had a large number of a protein called HER2 you would also have a targeted cancer drug called trastuzumab.

We know from research in other cancers that having more treatment (sometimes called maintenance therapy) after the first treatment can increase the time it takes for the cancer to come back. Researchers want to see if this also happens in people with food pipe cancer and stomach cancer.

In this trial the treatments they are looking at are:

Durvalumab is a type of targeted cancer drug called a monoclonal antibody. It seeks cancer cells by looking for a particular protein and attaching to it. By doing this durvalumab may help your immune system to attack your cancer and stop it from growing.

Capecitabine is a chemotherapy drug. It is used with other chemotherapy drugs to treat cancer of the food pipe and stomach.

Rucaparib is another targeted cancer drug. It blocks a protein (PARP) that helps cells repair themselves. By doing this it could stop the cancer growing.

Ramucirumab is also a targeted cancer drug. It is a monoclonal antibody. It works by blocking a receptor, called the vascular endothelial growth factor (VEGF), on the cancer cells. This stops the cancer growing new blood vessels. By doing so ramucirumab can stop the cancer from growing. Research has shown ramucirumab either by itself or in combination with chemotherapy can help people with stomach cancer. In this trial researchers are looking at ramucirumab in combination with capecitabine.  

The aims of this trial are to find:

  • if having additional treatment can increase the time before these cancers come back
  • if having more treatment can help people live longer
  • what the side effects are

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if you have one of the following cancers that has spread into the nearby tissue (locally advanced) or has spread to another part of the body (metastatic) and cannot be removed with surgery

And

  • It is known if your cancer is HER2 negative or HER2 positive
  • You have had at least 6 cycles of the chemotherapy that doctors use first to treat your cancer spread
  • You had a CT scan after your first course of treatment has finished that shows your cancer had got better or had remained the same
  • You are able to start treatment for this trial within 28 days after finishing your earlier chemotherapy
  • There are samples of your cancer tissue available from when you were diagnosed
  • You have an area of cancer spread that can be measured on a scan
  • If you had chemotherapy or radiotherapy as part of your treatment before your cancer had spread it must have been completed at least 6 months before your cancer had spread to another part of the body
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 7 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply

  • Your cancer is a type called squamous cell
  • After chemotherapy you are able to have surgery to remove your cancer and chemoradiotherapy
  • Your cancer has spread to the brain or spinal cord
  • You have had radiotherpay for your cancer spread, you might be able to join if it was for symptom control such as bone pain
  • You still have side effects from any previous treatment apart from mild side effects and moderate peripheral neuropathy
  • You have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer or in situ carcinoma of the cervix
  • You have certain heart problems
  • You have, or have had, inflammation of the lungs such as pneumonitis
  • You have HIV, hepatitis A, hepatitis B or hepatitis C
  • You have high blood pressure that isn’t controlled by medication
  • You have a problem with your digestive system
  • You are unable to swallow tablets or capsules
  • You have had major surgery in the past 4 weeks
  • You are already in a clinical trial unless it isn't a treatment trial
  • You have taken an experimental drug as part of another clinical trial in the past 30 days 
  • You have any other medical condition or mental health problem that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

For people without the HER2 protein (HER2 negative) you cannot join if any of the following also apply. You

  • Have DPD deficiency or are unable to take capecitabine for another reason
  • Have already had treatment with a drug similar to rucaparib, a PARP inhibitor
  • Are taking medication such as steroids that affect your immune system apart from nasal sprays and inhalers. If you are taking steroid tablets and the dose is no more than 10mg a day you may also be able to join
  • Have had an autoimmune disease in the past 2 years apart from vitiligo, Grave’s disease or psoriasis that has not needed treatment that reaches your whole body (systemic treatment)
  • Have, or have had, an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
  • Have a disease that affects how your immune system works
  • Have had tuberculosis
  • Are sensitive to durvalumab or any of its ingredients
  • Have had a live vaccine within 30 days of agreeing to take part

For people with HER2 protein (HER2 positive) you cannot join if any of the following also apply

  • Your heart does not work well enough. You will have a test to find this out
  • You are sensitive to trastuzumab or any of its ingredients

Trial design

This is a phase 2 trial. There are 5 groups in this trial. The team need 154 people to join each group.

There are 2 parts to this trial. Which part you go into depends on if your cancer has the HER2 protein (HER2 positive) or doesn’t have the HER 2 protein (HER2 negative).

People with HER2 positive cancer have trastuzumab.

You have trastuzumab as a drip into a vein every 3 weeks. You continue to have trastuzumab as long as it is helping you and the side effects aren’t too bad.

For people with cancer that is HER2 negative there are 5 groups:

  • regular follow up (surveillance)
  • capecitabine
  • durvalumab (MEDI4736)
  • rucaparib
  • ramucirumab and capecitabine 

For surveillance you see the doctor in the follow up clinic every month. But you have no treatment. This is called the control group. You continue seeing the doctor every month until your cancer starts to grow again. They will then talk to you about any other treatment that may be available to you and how often they want to see you.

Capecitabine is a tablet. You take them in the morning and the evening with a glass of water 30 minutes after a meal. You continue to have capecitabine as long as it is helping you and the side effects aren’t too bad.

You have durvalumab as a drip into a vein every 2 weeks. Every 4 week period is called a cycle of treatment. You can have up to 12 cycles of durvalumab as long as it is helping you and the side effects aren’t too bad.

Rucarpib is a tablet you take twice a day. Your doctor will tell you how many you take. You continue to have rucaparib as long as it is helping you and the side effects aren't too bad. 

You have ramucirumab as a drip into a vein. You have ramucirumab once a week for 2 weeks and then have a week of no treatment. This 3 week period is called a cycle of treatment. You continue to have treatment as long as it is helping you and the side effects aren't too bad. 

Blood and tissue samples

The researchers will take regular blood samples during your treatment. They will also take one when your cancer comes back.

They will also ask your permission to take a sample of tissue (biopsy) when you have your 2nd treatment and if your cancer comes back. You don’t have to agree to these biopsies. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • heart trace (ECG)
  • people with HER2 positive cancer will also have a heart scan (ECHO or MUGA)
  • CT scan

Depending on which treatment you are having you see the doctor every 3 or 4 weeks for a physical examination and blood tests. You have a CT scan every 12 weeks. People with HER2 positive cancer will also have a heart scan every 12 weeks.

A month after finishing treatment you see the doctor for the same tests you had at the start.

You have a CT scan every 12 weeks until your cancer starts to grow.

If you stopped treatment before your cancer started to grow you see the  doctor every 4 weeks until your cancer starts to grow again.

Side effects

You will be monitored closely during the trial and you should tell the trial team about any side effects you have.

The most common side effects of durvalumab reported include:

You might have a reaction when having durvalumab, or several days after. Tell your doctor or nurse straighta away if you have any of the following:

  • high temperature (fever)
  • chills
  • change in blood pressure 
  • difficulty breathing

The most common side effects of rucaparib include:

  • tummy (abdominal) pain
  • a drop in blood cells causing an increased risk of infection, bruising and bleeding
  • loss of appetite
  • tiredness
  • increased amount of cholesterol in the blood
  • constipation or diarrhoea
  • change to the way the kidneys work
  • dizziness
  • headaches
  • indigestion
  • high temperature (fever) with a low number of white blood cells (febrile neutropenia) 
  • feeling or being sick
  • high temperature 
  • change to the way the liver works

The most common side effects of ramucirumab with capecitabine include:

  • a drop in blood cells causing an increased risk of infection, bruising and bleeding
  • a low level of a protein called albumin in the blood
  • high blood pressure
  • nose bleeds
  • bleeding from the digestive system 
  • sore mouth and lips
  • diarrhoea
  • protein in the urine
  • tiredness and feeling weak
  • swollen hands and feet
  • rash on the hands and feet

By itself another common side effect of ramucirumab is tummy (abdominal) pain. 

We have information about the side effects of:

Your doctor will talk to you about the possible side effects before you agree to take part.

Location

London
Sutton

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 David Cunningham

Supported by

Experimental Cancer Medicine Centre (ECMC)
MedImmune LLC (wholly-owned subsidiary of AstraZeneca)
The Royal Marsden NHS Foundation Trust

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11683

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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