A trial looking at chemotherapy before and after surgery for advanced peritoneal cancer (Neo-ESCAPE)

Please note this trial is no longer recruiting patients.

This study is looking at a new way of giving paclitaxel and carboplatin chemotherapy, and whether adding another drug called gemcitabine helps in treating advanced cancer of the ovary, fallopian tube or peritoneum.

The first treatment for ovarian cancer is often surgery to remove as much of the cancer as possible. Many women also have chemotherapy following surgery. But if the cancer is at a more advanced stage when it is diagnosed, it may not be possible to remove it with surgery. You may have chemotherapy first to shrink the tumour so that surgery might be possible later on.

Two chemotherapy drugs that doctors often use to treat ovarian cancer are carboplatin and paclitaxel. You usually have these drugs at the same time. But some research has suggested that having the drugs separately may be better.

The researchers also want to see if adding in another drug called gemcitabine improves the chemotherapy treatment. Gemcitabine is already used to treat other cancers such as lung cancer and pancreatic cancer. And it has shown encouraging results for some women with ovarian cancer. You will have gemcitabine at the same time as one of the other drugs.

The aims of the trial are to

Find out more about having chemotherapy both before and after surgery
See if having chemotherapy in this way helps women with ovarian cancer
Learn more about the side effects

Recruitment

Start 01/11/2007

End 25/05/2011

Phase

Phase 2

Who can enter

You can enter this trial if you

Have recently been diagnosed with ovarian, primary peritoneal, or fallopian tube cancer and the diagnosis has been made by looking at a sample of tissue under the microscope
Have cancer that is stage 3C or 4
Are not able to have surgery to remove your cancer as your first treatment and your doctors recommend that you have chemotherapy to begin with
Are well enough to take part (performance status 0, 1, 2 or 3)
Have satisfactory blood test results and heart trace (ECG)
Are willing to use reliable contraception if there is any chance you could become pregnant
Are at least 18 years old

You cannot enter this trial if

Your doctor recommends surgery as your first treatment
You have cancer that your doctor describes as mucinous, classic clear cell or a borderline tumour
You have cancer that has spread to your brain
You have had any other cancer, apart from non melanoma skin cancer, carcinoma in situ of the cervix or another cancer that was not treated with chemotherapy and has been in complete remission for at least 5 years
You have diabetes
You have high blood pressure as a result of smoking
You have had a stroke in the last year
You have another serious medical condition such as (but not limited to) certain respiratory conditions, seizures that are not controlled with medicine, osteoarthritis, nerve damage or an infection
Are over 75 years old

Trial design

This trial will recruit 62 women at a number of hospitals in the UK.

Everybody taking part will have chemotherapy followed by surgery, then more chemotherapy. You will have 12 cycles of treatment in total, over a period of 7 or 8 months.

After 6 cycles of treatment, you will have a CT scan to see how well it has worked. Depending on the results of the scan, your doctors may recommend that you have surgery to remove as much of the cancer as possible.

If your doctors don’t think that you should have an operation after the first 6 cycles of chemotherapy, you will start the next 6 cycles of chemotherapy. You may be able to have surgery later on. If you do have surgery after 6 cycles of treatment, the second part of the chemotherapy will start after you have recovered from your operation.

Before surgery, you have carboplatin in 3 weekly cycles of treatment. After surgery, you have paclitaxel and gemcitabine in 2 weekly cycles.

You have the chemotherapy drugs through a drip into a vein. When you have carboplatin, it takes about an hour. Having gemcitabine takes about 30 minutes, and paclitaxel takes 3 hours. You have an anti histamine and steroid medicine each time you have paclitaxel to try and prevent an allergic reaction.

Everybody taking part in the trial will be asked to fill in some questionnaires before they start treatment, after surgery, before each cycle of chemotherapy they have after surgery and at the end of treatment. The questionnaires will ask you about any symptoms or side effects you have and about how you have been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
CT scan
Blood tests
Heart trace (ECG)
X-rays

Throughout your treatment, you have to go hospital every week for chemotherapy or blood tests or both.

After you finish treatment, you will see the doctors

Every 3 months for the first 2 years
Every 4 months the next year
Every 6 months for 2 years after that
Then once a year up to year 10

Side effects

The most common side effects of the chemotherapy drugs used in this trial are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and shortness of breath
Feeling or being sick
Hair loss - particularly with paclitaxel in the last 6 cycles of chemotherapy
Numbness and tingling in your hands and feet (peripheral neuropathy)
Muscle aches and pains

There is more information about carboplatin, paclitaxel and gemcitabine on CancerHelp UK.