A trial of palifosfamide-tris with doxorubicin for soft tissue sarcoma (PICASSO 111)

This study is looking at a new drug called palifosfamide-tris alongside doxorubicin for soft tissue sarcoma.

If soft tissue sarcoma has spread into surrounding tissue or to other parts of the body, doctors usually treat it with chemotherapy. A drug they often use is called doxorubicin.

Sadly this treatment does not work for everyone. Doctors want to try a new drug called palifosfamide-tris alongside doxorubicin to see if this combination of drugs works better then doxorubicin alone.

Palifosfamide-tris works by sticking together the cancer cell’s DNA so that it can't come apart again. This means that the cell can't reproduce itself. So this treatment could help to stop the cancer growing.

The aim of this study is to find out if doxorubicin and palifosfamide-tris together is better at treating soft tissue sarcoma that has spread than doxorubicin alone.

Recruitment

Start 18/02/2010

End 31/05/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

Have soft tissue sarcoma that has spread to other parts of the body
Have sarcoma that can be measured on CT scan
Are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception while you are on the study and for 3 weeks after if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewings sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumour or carcinosarcoma, osteosarcoma, radiation induced sarcoma, low grade (grade 1) sarcoma
Have already had treatment for sarcoma that has spread
Have cancer that has spread to your brain
Have any serious medical condition that the trial doctors think will affect you taking part including problems with your heart, kidneys or bladder
Have an infection that needs treatment
Have had major surgery in the last 4 weeks, or minor surgery in the last 2 weeks
Have had any radiotherapy in the last 4 weeks, unless it was to help control symptoms of your cancer (palliative radiotherapy)
Have had any other cancer apart from carcinoma in situ of the cervix, non melanoma skin cancer or early stage bladder cancer that was successfully treated at least 5 years ago
Are pregnant or breastfeeding

Trial design

This trial will recruit about 424 people from around the world.

This is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in either. This is called a blind trial.

You have treatment in 3 week periods called cycles of treatment.

People in group 1 have doxorubicin and palifosfamide-tris through a drip into a vein on day 1 of each treatment cycle. They have palifosfamide-tris alone on the next 2 days of each cycle.

People in group 2 have doxorubicin and a dummy drug (placebo) on day 1 of each treatment cycle. And they have just the dummy drug on the next 2 days of each cycle.

You will have up to 6 cycles of treatment.

You will be asked to fill out a questionnaire

Before you start treatment
On days 1 of cycle 3 and 5
21 days after you have finished treatment
Every 8 weeks for the next 6 months
Then every 6 months

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.

Hospital visits

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

Physical examination
Blood tests
Urine test
Heart trace (ECG)
CT scan
Heart ultrasound (echocardiogram) or MUGA scan

In every cycle you go to hospital for treatment on days 1, 2 and 3. In cycle 1 you also go to have blood tests on days 8 and 15. From cycle 2 onwards you will have blood tests on day 15 only.

You will have CT scans every 6 weeks while you are having treatment.

3 weeks after you finish the treatment, you see the research team for a physical examination and a repeat of all the tests and scans you had when you joined the trial.

After this visit, you will have a CT scan and see the doctor every 8 weeks for 6 months and then every 12 weeks until your cancer starts to grow again. When your cancer starts to grow again, the doctor will see you in clinic or contact you by phone every 12 weeks until you start a different treatment.