A trial looking at capecitabine with or without bevacizumab for colorectal cancer (QUASAR 2)

Who can enter

You can enter this trial if you

• Have stage 3 colorectal cancer or stage 2 colorectal cancer, which your doctors think has a high risk of spreading to another part of the body
• Had surgery to remove all of your colorectal cancer between 4 and 10 weeks ago
• Are well enough for treatment (performance status 0 or 1)
• Have satisfactory blood test results
• Are prepared to use effective contraception if there is any chance either you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have had chemotherapy, immunotherapy or radiotherapy before
• Have had any other trial treatment in the last 4 weeks
• Regularly take medication to thin your blood (anti coagulants) or have blood that doesn’t clot quickly enough
• Are taking the anti viral drugs sorivudine or brivudine
• Have chronic inflammatory bowel disease, bowel obstruction, a stomach ulcer or any other condition that means you are not able to take or absorb tablets
• Have heart disease, or have had a stroke or heart attack in the last year
• Have had any other cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix
• Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit 2,240 patients into 2 groups. The trial is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have capecitabine. You take capecitabine tablets twice a day (12 hours apart) for 2 weeks out of every 3. Then you don’t take any in the 3rd week. Each 3 week block is one cycle of chemotherapy. You have 8 cycles over about 6 months altogether.

If you are in group 2, you will have capecitabine and bevacizumab. You take capecitabine tablets as for group 1 above. On the first day of each 3 week cycle you have bevacizumab through a drip into a vein. This takes about an hour and a half for first dose, about an hour for the second dose, and about half an hour for each dose after that.

You have 8 cycles of capecitabine over about 6 months. But you have 16 cycles of bevacizumab, so treatment will take about 12 months altogether.

Hospital visits

You will see the doctors and have some blood tests and a urine test before you start the trial.

If you are in group 1 you will go to hospital once every 3 weeks to see the doctors and pick up your capecitabine tablets.

If you are in group 2 you go to the hospital once every 3 weeks to pick up your capecitabine tablets and to have the bevacizumab injection. You will have blood tests and urine test before each dose of bevacizumab.

After you finish treatment you will see the doctors every 6 months for a year and then once a year after that.

Side effects

The most common side effects of capecitabine are

• Diarrhoea
• Mouth ulcers
• Feeling or being sick
• A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
• Redness and soreness on hands and feet (palmar-planter syndrome)

The most common side effects of bevacizumab are

• Increase in blood pressure
• Skin irritation
• Tiredness
• Bleeding problems
• Loss of appetite

There is more information about capecitabine (Xeloda) and bevacizumab (Avastin) on CancerHelp UK.