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

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  or elsewhere in the body
• You have a type of cancer called transitional cell  cancer or squamous cell cancer
• 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 )
• 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  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 to have cabozanitinib if any of the following apply. 

Cancer related
You:

• 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  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
You:

• 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  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
You:

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

• Have had treatment with a PARP inhibitor in the past
• Are allergic to rucaparib or anything it contains
• Have a stent in your tummy and/or any other digestive problem that would interfere with how you absorb rucaparib
• Have had myelodysplastic syndrome in the past
• Have any other medical condition that the study doctor thinks could affect you taking part
• Have cancer spread to the brain or spinal cord that is causing symptoms and/or is untreated
• Take warfarin or clopidogrel to thin the blood – you might be able to join if you take low dose aspirin