A trial looking at decitabine and carboplatin for advanced ovarian cancer

Please note this trial is no longer recruiting patients.

This trial is comparing a combination of decitabine and carboplatin chemotherapy with carboplatin alone as treatment for ovarian cancer that has come back.

Doctors usually treat ovarian cancer with surgery and then chemotherapy. But sometimes the cancer comes back (relapses) after treatment. If this happens, doctors will probably recommend that you have more chemotherapy.

If the chemotherapy drug carboplatin worked well for you before, your doctor will probably suggest you have it again because your cancer may still be sensitive to it. But unfortunately cancer can become resistant to this chemotherapy.

Research carried out in laboratories has shown that a drug called decitabine can make resistant cancer cells respond to chemotherapy drugs again. Decitabine is already in use for myelodysplastic syndromes. It works by changing the activity of some of the genes in the cells. Doctors hope that adding this new drug will help the chemotherapy to work better. But they are not sure yet.

The aims of this trial are to

See how well decitabine works with carboplatin for relapsed ovarian cancer
Find out more about the side effects

Recruitment

Start 23/07/2007

End 18/12/2008

Phase

Phase 2

Who can enter

You can enter this trial if

You have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has come back after chemotherapy
Your cancer came back between 6 and 12 months after you finished your chemotherapy
You had chemotherapy that included a platinum drug (carboplatin or cisplatin)
You are well enough to take part in the trial
You have satisfactory blood test results
You are willing to use reliable contraception during the trial (as well as for 4 weeks before and 6 months after) if there is any chance you could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have already had more than two chemotherapy regimes and there was less than 6 months between the 2 different treatments
Have had radiotherapy, chemotherapy, biological therapy or hormone therapy, in the last 4 weeks
Still have side effects from earlier chemotherapy
Had a bad reaction to carboplatin in the past
Have any other cancer apart from carcinoma in situ of the cervix or non melanoma skin cancer that have been successfully treated or any other cancer that was successfully treated at least 5 years ago
Have had major surgery to your chest or abdomen in the last 4 weeks
Have another serious medical condition
Are known to be HIV, Hepatitis B or Hepatitis C positive
Are pregnant

Trial design

This is a phase 2 trial. It will recruit 134 people at 11 hospitals around the UK. It is a randomised trial. This means that everybody taking part will be put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

You will have chemotherapy in 4 week (28 day) cycles of treatment. You will have 6 cycles of treatment, lasting about 6 months in all.

If you are in group 1, you will have carboplatin through a drip into a vein on the first day of each cycle. This will take between 30 minutes and 1 hour. You will have a number of blood tests during each cycle to check your blood cell counts and see what effect the carboplatin is having on your blood.

If you are in group 2, you will have decitabine through a drip into a vein on the first day of each cycle. This will take about 6 hours. On day 8 of each cycle, you will have carboplatin through a drip into a vein. This will take between 30 minutes and 1 hour. You will have a number of blood tests during each cycle to check your blood cell counts, see what effect the 2 drugs are having on your blood, and see how you are responding to the treatment.

Sometimes fluid can build up in your abdomen. This is called ascites. This can become very uncomfortable and your doctor may suggest draining some of it off. If you do have ascites, the researchers may ask to take a sample of the fluid before your treatment. If the fluid builds up again, they will take another sample during the 2nd cycle of treatment. This is because the fluid may contain cancer cells and the researchers want to see how the drugs are affecting them.

The trial team may ask if they can take biopsies from your ovarian cancer before and after the treatment. This is so the researchers can see how the drugs are affecting the cancer cells. You can refuse these extra biopsies and still take part in the trial.

The doctors may also ask your permission to get a sample of the tissue taken when your ovarian cancer was first diagnosed. If you don’t agree to give tissue samples for research, you can still take part in the trial.

Hospital visits

You will go to the hospital to see the doctors and have a number of tests before you take part in this trial. These include

Physical examination
Heart trace (ECG)
Blood tests
Urine tests
CT scan
MRI scan
Chest X-ray

If you are in group 1, you will go to the hospital on day 1 of each treatment cycle. During the first cycle of treatment you will have 3 other hospital visits for blood tests. During each of the other 5 cycles, you will have 1 other hospital visit for a blood test.

If you are in group 2, you will go the hospital for treatment on day 1 and day 8 of each cycle. During the first cycle, you will have 3 other hospital visits for blood tests. During each of the other 5 cycles you will have 1 other hospital visit for a blood test.

Everybody taking part will have a CT scan after every 2 cycles of treatment (approximately every 8 weeks). You will also go to see the trial doctors, have more blood tests and a final CT scan 4 weeks after you finish your treatment.