A trial of decitabine and ECF chemotherapy for advanced cancer of the food pipe (oesophageal cancer)

Who can enter

You can enter this trial if you

• Have stage 3 or 4 oesophageal cancer
• Are well enough to take part in the trial (performance 0, 1 or 2)
• Have satisfactory blood test results
• Are willing to use reliable contraception while you are taking part in this trial if there is any chance you or your partner could become pregnant
• Are 18 years or older

You cannot enter this trial if you

• Have had chemotherapy in the past, except for chemotherapy to shrink the cancer before surgery (neo adjuvant chemotherapy)
• Have had radiotherapy in the past
• Have cancer that has spread to the brain from another part of your body (secondary brain tumour)
• Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer. (If you have been clear of cancer for 5 years or more since treatment, your doctor will tell you if you can take part in the trial)
• Have had a heart attack in the last 6 months
• Are pregnant or breastfeeding

This trial is also recruiting for stomach cancer. Please see the stomach cancer section of the database for more information.

Trial design

This is a phase 1 trial. All patients taking part will have decitabine and ECF chemotherapy.

The first three patients will have the lowest dose of decitabine. If they don't have any serious side effects, the next three patients will have a higher dose. And so on, until the doctors find the best dose to give. This is called a 'dose escalation study’. The dose of ECF will not change during the trial.

You will have up to 6 cycles of chemotherapy. The first cycle is a month (31 days), and after that, each cycle is 3 weeks. During each cycle, your chemotherapy treatments will be approximately 11 days apart. So, for cycle 1, you will have decitabine first (day 1) followed by ECF, 11 days later, and then decitabine, 11 days after that. To have ECF, you have an injection of EC and then have 5FU continuously. For cycles 2 to 6, you will have EC on day 1, followed by a continuous infusion of 5FU. You will then have an infusion of decitabine 11 days later. The whole course of treatment could take about 5 months.

You will have decitabine, epirubicin and cisplatin as a drip (infusion) through a central line. A central line is a small plastic tube, which you have. It is passed under the skin and into a vein under your collar bone. You will have some sedation when the doctors put your central line in.

You will also have 5FU continuously, through your central line, which will be connected to an infusion pump. The pump is a small machine, which automatically ‘pumps’ the chemotherapy into your blood stream very slowly each day. Your doctor will give you more information about the line and the pump nearer the time.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

• Biopsy
• CT scan
• Heart trace (ECG)
• Chest X-ray
• Physical examination
• Blood tests
• Blood pressure and heart rate

You will go to hospital at the start of your chemotherapy to have a central line put in. You will have sedation before you have this.

During each treatment cycle you will stay in hospital overnight when you have ECF. And you will stay on the hospital ward for the day when you have decitabine.

After you have your first injections of epirubicin and cisplatin, your 5FU pump will be connected up. The pump will stay connected to your central line when you go home. You will need to go back to the hospital every 7 days to have your 5FU pump renewed.

After you have your second cycle of epirubicin and cisplatin, you will have a biopsy.

You will have a CT scan after 3 cycles of chemotherapy. You may have up to 6 cycles of treatment, depending on how well the treatment works.

Side effects

As with all treatments, ECF and decitabine have some side effects.

The most common side effects of ECF are

• A drop in blood cells causing increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Feeling or being sick
• Hair loss
• Diarrhoea

The most common side effects of decitabine are

• A drop in blood cells causing increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Feeling or being sick

There is more about the side effects of ECF on CancerHelp UK.