A trial of more treatment after chemotherapy for advanced urinary tract cancer (urothelial cancer) (ATLANTIS)

Cancer type:

Bladder cancer
Kidney cancer

Status:

Open

Phase:

Phase 2

This trial is testing different treatments for different subtypes of urinary tract cancer. It is for people whose cancer has grown into surrounding tissues or spread elsewhere in the body (advanced cancer).

The urinary tract includes the:

  • centre of the kidney (renal pelvis)
  • tube that takes urine from the kidney to the bladder (ureter)
  • bladder
  • tube that drains urine from the bladder and out of the body (urethra)

Cancer Research UK supports this trial.

More about this trial

Chemotherapy is one of the usual treatments for advanced urothelial cancer. After chemotherapy, you have regular monitoring. This means you don’t have treatment straight away. Your doctor keeps a close eye on you to check for any signs that the cancer is growing. If it does, then you and your doctor decide which treatment is best for you.

Researchers are looking at ways to delay the cancer growing again after chemotherapy. We know from research in other cancers that having more treatment (sometimes called maintenance therapy) can increase the time it takes for the cancer to come back. Researchers want to see if this also happens in people with advanced urinary tract cancer.

But not all urinary tract cancers are the same and some new cancer drugs may help people with one type of urinary tract cancer more than another.

To work out the subtype of urinary tract cancer you have, the researchers will test a sample of your cancer (biopsy Open a glossary item) to look for changes to certain genes and proteins (biomarkers Open a glossary item).

The trial team hope to test a number of different treatments. But for now, there is only one part of the trial that is open. This part is called ATLANTIS-1 and it is looking at a drug called cabozantinib. This is a type of targeted cancer drug (biological therapy Open a glossary item).

Cabozantinib works in 2 different ways. It blocks particular proteins on cancer cells. These proteins encourage the cancer to grow. It also stops the cancer cells growing blood vessels, which the cells need to be able to grow. Researchers hope that cabozantinib might delay the cancer growing for a time.

The overall aims of this trial are to find out:

  • 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 might be able to join the trial if all of the following apply.

  • You have urothelial cancer that started in the middle of the kidney (the renal pelvis), ureter, bladder or urethra
  • Your cancer has spread to the wall of the tummy (abdomen) or between the hips (pelvis) or to the lymph nodes Open a glossary item or elsewhere in the body
  • You have a type of cancer called transitional cell Open a glossary item cancer or squamous cell cancer Open a glossary item
  • You have had chemotherapy as the first treatment for the cancer spread and you have had between 4 and 8 cycles
  • There is a tissue sample available for the trial team to do some tests
  • It is possible to start trial treatment within 10 weeks of finishing chemotherapy
  • You are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • You are willing to use reliable contraception during treatment if there is any possibility you or your partner could become pregnant
  • You have satisfactory blood test results
  • You must be willing to use reliable contraception during treatment and for 4 months afterwards if there is any possibility you or your partner could become pregnant
  • You must be able to swallow tablets
  • You are at least 16 years old

You cannot join this trial if any of these apply.

  • A scan showed your cancer got worse during the first chemotherapy you had for advanced cancer
  • You have had more than 1 course of chemotherapy for advanced cancer – you might still be able to take part if you had to change to a different type of chemotherapy due to bad side effects
  • It has been less than 3 weeks or more than 10 weeks since your last chemotherapy treatment
  • The trial doctor thinks further chemotherapy will help you
  • You are due to have surgery or radiotherapy after chemotherapy unless you are having radiotherapy to control symptoms – (palliative radiotherapy Open a glossary item)
  • You have had major surgery or radiotherapy within 3 weeks of joining the trial or palliative radiotherapy within 2 weeks
  • You have had any other cancer in the last 2 years apart from carcinoma insitu of the cervix  or non melanoma skin cancer Open a glossary item that was successfully treated or early prostate cancer and you don’t need hormone treatment
  • Your kidneys, liver or other organs in the body aren’t working properly
  • You have had any other treatment as part of a clinical trial in the last 28 days
  • You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

As well as the above
You cannot join ATLANTIS-1, if any of the following apply. You

Cancer related

  • Have cancer that has spread to your brain or tissues covering your brain unless this has been treated with surgery or radiotherapy, has not got worse in the 4 weeks before starting the trial, and you are no longer taking steroids
  • Have cancer that has grown into a major vein in the lungs
  • Have had a type of drug called a tyrosine kinase inhibitor such as axitinib or pazopanib
  • Have had treatment with cancer drugs that affect certain proteins such as MET crizotinib and VEGF such as bevacizumab, sorafenib and vandetanib
  • Have had any targeted cancer drug in the 4 weeks before joining the trial
  • Have had chemotherapy in the last 3 weeks (6 weeks if you had chemotherapy drugs called nitrosoureas Open a glossary item or mitomycin C)
  • Have had radiotherapy in the 4 weeks before joining the trial. You might be able to join if you have had palliative radiotherapy which finished at least 2 weeks before joining the trial
  • Have had a radioactive treatment called Yttrium or radioactive iodine in the 6 weeks before starting the trial
  • Have had cabozantinib or a similar drug

Medical conditions

  • Take warfarin or clopidogrel to thin the blood – you might be able to join if you take low dose aspirin
  • Have an area in your lung called a cavitating lesion or your cancer or another lung condition is causing endobronchial disease
  • Have problems with your heart such as congestive heart failure that is causing symptoms, high blood pressure that is not well controlled, angina that is not well controlled or an abnormal heart rhythm
  • Have had a stroke, heart attack, or a blood clot (for example in your leg or lung) in the last 6 months
  • Have a problem with your digestive system Open a glossary item such as a hole, blockage or an abnormal opening called a fistula in your gut, or a collection of pus (an abscess) in your tummy (your abdomen) in the 6 months before starting the trial or you have a condition called malabsorption syndrome
  • Have had a large bleed or vomited blood in the last 3 months
  • Have an underactive thyroid (hypothyroidism) which is causing symptoms and which is not being treated
  • Have a wound, ulcer or bone fracture that is not healing
  • Have an infection that needs treatment
  • Have hepatitis B or hepatitis C
  • Have HIV
  • Have had an organ transplant (kidney, liver, lung, heart)

Other

  • Take certain medications that can affect body substances called CYP enzymes
  • Are sensitive to cabozantinib or anything it contains

Trial design

This phase 2 trial is based in the UK. The part of the trial called ATLANTIS-1 is open. The researchers need 140 people to join.

The doctors test a sample of your cancer taken when you had a previous biopsy or surgery. They will try to classify your cancer as a particular subtype.

ATLANTIS-1
If you don’t have a specific biomarker being looked at (you are biomarker negative), you might be suitable to join this part of the trial.

It is a randomised trial. You are put into 1 of 2 groups to have 1 of the following:

  • cabozantinib
  • dummy drug (placebo Open a glossary item)

ATLANTIS Trial Diagram

Neither you nor your doctor will be able to decide which group you are in. And neither of you will you know which group you are in. This is called a double blind trial.

Cabozantinib and the dummy drug are tablets. They look the same and come in the same packaging. You take them once a day, everyday. The trial team will give you a fresh supply of tablets every 4 weeks.

You have treatment as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.

Research samples
The trial team will ask to take some extra blood samples as part of this trial. This is to look for biomarkers Open a glossary item. Where possible, you have these at the same time as your routine blood tests.

Biomarkers help to predict who is most likely to benefit from this treatment and also help us to better understand advanced urinary tract cancers.

You don’t have to give these samples if you don’t want to. You can still take part in the trial.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • physical examination
  • heart trace (ECG Open a glossary item)
  • blood tests
  • urine tests
  • MRI scan or CT scan

You see the trial team once a month for a check up and some blood tests. You have a CT scan or MRI scan every 3 months.

When you finish treatment you see the trial team:

  • a month later
  • every 3 months

Side effects

The most common side effects of cabozantinib include:

You should avoid grapefruit and Seville oranges as they might increase the levels of cabozantinib in the body.

The trial team will talk to you about all the possible side effects before you agree to join.

Location

Bournemouth
Glasgow
Leicester
Manchester

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 Robert Jones
Professor Thomas Powles

Supported by

Cancer Research UK
Exelixis
NHS Greater Glasgow and Clyde
University of Glasgow

Other information

This is Cancer Research UK trial number CRUK/14/042.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12868

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:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think