A trial looking at gemcitabine with AMG 479 for pancreatic cancer that has spread - GAMMA

Who can enter

You may be able to enter this trial if you

• Have the most common type of pancreatic cancer called adenocarcinoma that has spread to another part of the body
• Have satisfactory blood test results
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0,1)
• Are willing to use reliable contraception during treatment and for 6 months after if there is a chance you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have a cystic tumour called a cystadenocarcinoma , cancer of the islet cells, cancer of the acinar cells, sarcoma of the pancreas, lymphoma of the pancreas or cancer that started in the biliary tree
• Have cancer that has spread to your brain or spinal cord (central nervous system)
• Have already had treatment for your pancreatic cancer
• Have had fluid drained from your tummy area (abdomen) or you’re your chest in the last 2 weeks
• Have had major surgery in the last month, or have not yet recovered from major surgery
• Have had minor surgery in the last 7 days or have not yet recovered from minor surgery – you may join the trial if the minor surgery was to place a central line, PICC line or similar device, a fine needle aspiration or a biliary stent placed using endoscopy
• Have had another cancer apart from non melanoma skin cancer, lentigo maligna, cervical in situ carcinoma or an overgrowth of abnormal cells in the lining of the prostate or any other cancer that has been successfully treated and there has been no sign of it in the last 3 years
• Have had a heart attack in the last 6 months
• Have heart pain (angina) or heart failure that is not controlled by medication
• Have had medication as part of another clinical trial in the last month
• Have had medication for an infection in the last 7 days
• Are known to be sensitive to the drugs used in this trial
• Are known to be HIV, hepatitis B or hepatitis C positive
• Have another condition that could affect you taking part in this trial

Trial design

This is a phase 3 international trial. It will recruit about 825 people from different countries around the world.

It is a randomised trial. You will be put into 1 of 3 treatment groups. Neither you nor your doctor can choose which group you are in. Nor will you or your doctor know which group you are in. This is called a double blind trial.

If you are in group 1, you have AMG 479 and gemcitabine.

If you are in group 2, you have a higher dose of AMG 479 and gemcitabine.

If you are in group 3, you have a dummy drug (placebo) and gemcitabine.

You have both drugs through a drip into a vein in 4 week cycles of treatment. In each treatment cycle, you have gemcitabine on days 1, 8 and 15. This takes half an hour each time.

You have AMG 479 or the dummy drug on days 1 and 15. In the first cycle you have these over 1 hour on both days. If you don’t have a reaction, you can have them over 30 minutes for later cycles. But if you do have a reaction, the time it takes to have the drug is increased to 2 hours for later cycles.

As long as you don’t have any bad side effects you can continue to have treatment for as long as it helps you.

You will be asked to fill in a questionnaire before you start treatment, at regular times during treatment and at the end of treatment. It will ask you how you are feeling and about any side effects you may have. This is called a quality of life questionnaire.

Hospital visits

You will see the doctor and have some tests before taking part in this trial. These tests include

• A physical examination
• Heart trace – ECG
• Hearing test
• CT scan or MRI scan
• Blood tests
• Urine test

During treatment you see the doctor and have blood tests on days 1, 8 and 15 of each cycle. You have another hearing test at the start of cycle 3. You have a CT or MRI scan every 8 weeks.

About 1 month after finishing treatment you see the doctor and have the following tests

• A physical examination
• Blood tests
• Hearing test
• Heart trace – ECG

After the end of the trial, you will then see the doctor every 3 months, or they will telephone you to see how you are.

If you stop treatment before your cancer has started to grow again, you will have a CT scan or MRI scan every 8 weeks until it starts to get worse.

Side effects

AMG 479 is a new drug and we are not sure what the side effects are. But the most common side effects reported by people who have had AMG 479 in other trials include

• Tiredness
• Feeling cold
• A drop in blood cells causing an increased risk of infection, bruising or bleeding
• Feeling or being sick
• Rash and itchy skin
• Loss of appetite
• Weight loss
• Diarrhoea or Constipation
• Changes to the way your liver works
• A decreased level of magnesium, potassium and thyroid hormone in your blood
• An increased level of sugar in your blood or urine
• A reaction to the drug causing chills, low blood pressure, fast heart rate, fever, flushing, sweating and breathlessness
• Sore or dry mouth
• A type of fungal infection called thrush
• Feeling weak
• Pain
• Hair loss
• Taste changes
• Dizziness
• High blood pressure
• Swelling in your arms and legs
• Sweating, particularly at night (night sweats)

You can find information about the side effects of gemcitabine on CancerHelp UK.