A trial looking at AG-013736 for metastatic or locally advanced thyroid cancer that cannot be treated with radioactive iodine or doxorubicin

Who can enter

You can enter this trial if

• You have been diagnosed with papillary, follicular or Hürthle-cell thyroid cancer
• Your cancer is resistant to doxorubicin OR you are unable to take doxorubicin because of bad side effects OR you have already had a high dose of doxorubicin - your doctor will advise you about this
• Your cancer cannot be removed by surgery or treated with radiotherapy
• You have satisfactory blood test results
• You are well enough to take part in the trial
• You are prepared to use reliable contraception while you are taking part in the trial (and for 6 months afterwards) if there is any chance that you or your partner could become pregnant
• You are at least 18 years of age

You cannot enter this trial if

• You have medullary thyroid cancer, anaplastic thyroid cancer or thyroid lymphoma
• You have cancer that has spread to any of the major blood vessels in your chest
• You have cancer that has spread to your brain or spinal cord
• You have had surgery in the last 4 weeks
• You have had a heart attack, a stroke, a deep vein thrombosis (DVT), a blood clot in the lung (pulmonary embolism) or a coronary artery bypass graft in the last year
• You have had any other type of cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that have been successfully treated
• You have had treatment for a peptic ulcer in the last 6 months
• You have had an endoscopy or colonoscopy in the last 3 months, that showed you were bleeding from somewhere in your digestive system
• You have fits or seizures
• You have high blood pressure that cannot be controlled with medicine
• You have been coughing up blood in the last week
• You have any other serious medical condition that could affect your taking part in the trial including (but not limited to) an infection, angina or heart failure
• You have any condition that makes it difficult for you to take or absorb tablets
• You have already had treatment with an anti angiogenic drug
• You are having any other drugs that may affect the way AG-013736 works - the trial doctor will advise you on this
• You are pregnant or breastfeeding

Trial design

This is an international trial. It will recruit 100 patients. Everybody taking part in the trial will have treatment with AG-013736 tablets. You will have AG-013736 for as long as it helps you.

You will have the treatment at home, but you will go to the hospital to have your first dose of AG-013736. The doctor will examine you and take your blood pressure. You will have a blood test just before you take the AG-013736 and another one 1 to 2 hours afterwards.

After the first dose, you will have AG-013736 tablets twice a day. The trial team will give you a blood pressure machine to use at home. You must take your blood pressure twice a day, before you take the tablets. You will have to write the results in a diary that the trial team will give you.

If your blood pressure is high, you must not take the tablets and you must contact the trial team. The trial doctor or nurse will show you how to use the machine, tell you what measurement is too high to take the tablets and explain how to contact them if this happens.

The doctors may increase or decrease the dose of tablets you have depending on whether or not you have any side effects and how bad they are.

If your dose is increased, you will have to take the first higher dose at the hospital. You will have a blood test just before you take the tablets and 4 more blood tests 1, 2, 3 and 4 hours after you take them.

The trial doctor or nurse will ask you to fill in questionnaires at the beginning of the trial, during your treatment and after you stop taking the tablets. These will ask about how you are feeling and any side effects you may have. They are called quality of life studies.

The trial doctor will advise you not to drink grapefruit juice, eat grapefruit or take the herbal preparation called St John’s wort during the trial.

Hospital visits

You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include

• Physical examination
• ECG
• CT scan or MRI scan
• Bone scan
• Blood tests
• Urine test

You will go to the hospital for your first dose of AG-013736 and at least once every 2 weeks for the first 8 weeks of your treatment. After that, you will go to the hospital every 4 weeks.

You will have an ECG after 4 weeks of treatment and regular blood tests during the trial.

Every 6 weeks, the doctors will measure how well the tablets are working. To do this, you will have either a CT scan or an MRI scan, depending on how your cancer was measured at the beginning of the trial. You will also have a bone scan every 12 weeks.

Your doctors will advise you to stop taking AG-013736 tablets if

• They can see that the tablets are not helping you
• The side effects are too bad
• You don’t want to carry on with the trial

About a month later, you will go to the hospital for a follow up visit. The doctor will examine you and you will have an ECG, a urine test, blood tests and a CT or MRI scan.

Side effects

As AG-013736 is a new drug, there may be some side effects that the doctors don’t know about yet. In trials so far, the most common side effects were

• Tiredness (fatigue)
• Feeling sick (nausea)
• An increase in blood pressure
• Protein in the urine
• A drop in white blood cells