A trial comparing different combinations of chemotherapy after surgery for women with ovarian cancer who have already had chemotherapy before surgery (PETROC/OV21)

This trial is comparing 3 different types of chemotherapy for women who have already had chemotherapy followed by surgery for ovarian cancer.

Doctors usually treat ovarian cancer with surgery to remove as much of the cancer as possible followed by chemotherapy. If your cancer has spread outside the ovary then it can be difficult for the surgeon to remove the cancer. So you may also have chemotherapy before your surgery.

Chemotherapy before surgery is called neoadjuvant chemotherapy. The chemotherapy may shrink the cancer so that it is then possible for the surgeon to remove it. This is called interval debulking surgery. You then have more chemotherapy after the surgery.

What doctors do not know is the best treatment to give after neoadjuvant chemotherapy and surgery. Often doctors give more chemotherapy that you have through a drip into a vein. We know from research that having some chemotherapy into the vein and some directly into the tummy (intraperitoneally) may be better at helping to stop the cancer from coming back.

In this study, researchers are looking at giving different chemotherapy drugs in different ways after surgery.

The aim of the study is to find out if chemotherapy into the tummy (abdomen) helps women with ovarian cancer who have had chemotherapy before surgery.

Recruitment

Start 01/05/2011

End 01/05/2013

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, clear cell ovarian cancer or primary serous type peritoneal cancer
Had ovarian cancer that had spread outside your ovaries (stage IIB to III) when you were diagnosed
Had 3 to 4 cycles of a chemotherapy that included a platinum drug before surgery to remove your cancer (debulking surgery)
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are aged 18 or over

You cannot enter this trial if you

Have had treatment for ovarian cancer other than 3 to 4 cycles of chemotherapy immediately before your surgery
Have any heart problems that are a cause for concern
Have a blockage in your bowel (bowel obstruction)
Have any serious illness that the trial doctors think could affect your taking part
Are already taking an experimental drug as part of another clinical trial
Have had any other cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated at least 5 years ago

Trial design

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

People in all 3 groups have treatment in 3 week periods called cycles of treatment.

People in group 1 have paclitaxel through a drip into a vein on day 1 of each treatment cycle. On day 8 they have paclitaxel and carboplatin through a drip into a vein.

People in group 2 have paclitaxel through a drip into a vein, and cisplatin through a tube into their tummy (abdomen) on day 1 of each cycle. On day 8 they have paclitaxel into their abdomen. Doctors call chemotherapy into the abdomen intraperitoneal chemotherapy.

People in group 3 have paclitaxel through a drip into a vein, and carboplatin into their abdomen on day 1. On day 8 they have paclitaxel into their abdomen.

You can have up to 3 cycles of treatment.

You fill out a questionnaire

Before you start treatment
At the beginning of cycles 2 and 3
When your treatment finishes
6 weeks after your treatment finishes
3, 6 and 12 months after the end of treatment
Then once a year until your cancer starts to grow again

The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. They will use this sample to learn more about ovarian cancer and how to treat it. If you do not want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

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

Physical examination
Blood tests
CT scan

On the first day of each treatment cycle you will have a physical examination. You will have a blood test before each treatment on days 1 and 8.

When you finish your treatment you will have a CT scan. This will be repeated every 6 months for 2 years and then once a year after that.

Side effects

The most common side effects of chemotherapy include

Tiredness (fatigue)
Feeling or being sick
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

Cisplatin can also cause kidney damage.

Paclitaxel has side effects that also include

Hair loss
Numbness and tingling in hands and feet (peripheral neuropathy)
Aching joints (arthralgia) and muscles (myalgia) it may start a couple of days after treatment and last for about 5 days

The most common side effects of intraperitoneal chemotherapy are