A study looking at paclitaxel with or without saracatinib for ovarian, fallopian tube or primary peritoneal cancer that has come back (SaPPrOC)

Please note this trial is no longer recruiting patients.

This trial is for women who have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that has come back within 6 months of being treated with platinum chemotherapy. This cancer is now called platinum resistant.

Platinum resistant ovarian cancer can be difficult to treat and doctors are looking at new combinations of drugs to help this group of women.

In this trial doctors want to treat people with weekly paclitaxel (Taxol) and tablets called saracatinib (also known as AZD 0530).

Usually you have paclitaxel every 3 weeks, but from previous research doctors think it may work better if you have it weekly. Doctors have also found that taking saracatinib with paclitaxel may help.

Sometimes a drug can stop working, even though cancer responded to it at first. Doctors call this resistance. Some trials have shown that saracatanib may help to stop cancer cells becoming resistant to other drugs.

The aim of this study is to see if having paclitaxel and saracatinib together are better at treating ovarian, fallopian tube and primary peritoneal cancer than paclitaxel alone.

Recruitment

Start 31/03/2011

End 09/05/2012

Phase

Phase 2

Who can enter

You can enter this trial if

Your ovarian cancer, fallopian tube cancer or primary peritoneal cancer has come back within 6 months of finishing platinum chemotherapy
Your cancer can be measured on CT scan
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Your blood test results are satisfactory

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord
Have one of the following tumour types - malignant mixed mesodermal (MMMT), mucinous subtypes, or non epithelial ovarian cancers (for example, Brenner tumours, sex cord tumours) – you can ask your doctor about this
Have not yet had chemotherapy with a platinum drug
Have had chemotherapy in the last 3 weeks
Have already had weekly paclitaxel
Have had radiotherapy in the last 3 weeks
Have had any treatment as part of another clinical trial in the last 4 weeks
Have taken any drugs that damp down your immune system (immunosuppressants) or steroids in the past 4 weeks
Have a blockage in your bowel (bowel obstruction)
Have heart failure
Have any infections or other illnesses that may affect you taking part in the trial
Have HIV, Hepatitis B or C
Are pregnant or breastfeeding

Trial design

This study will recruit 102 patients from 13 hospitals in the UK. It is a randomised trial.

The women taking part are put into 2 treatment groups by 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 ‘double blind’ trial

Women in group 1 have paclitaxel and saracatinib
Women in group 2 have paclitaxel and a dummy drug (placebo)

There will be 68 women in group 1 and 34 women in group 2. So 2 out of 3 women in this trial have the trial drug.

Women in both groups start to take saracatinib or placebo tablets one week before starting the paclitaxel and continue taking the tablets daily during the study.

You have paclitaxel weekly for 6 weeks, followed by 2 weeks break. This 8 week period is called a treatment cycle. You will have 4 cycles of treatment. But if the treatment is helping, you may be able to continue with the paclitaxel and saracatinib (or placebo) for longer. Your doctor will discuss this with you.

You will also be asked to fill out a questionnaire before you start treatment, 3 times during each treatment cycle and then every 3 months after you have finished treatment. The questionnaire will ask about any side effects you have had and 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 your permission to take a sample of your cancer, from when you had your original surgery. They will also ask your permission to take 2 extra blood samples, 1 will be taken before you start taking saracatinib or placebo, and 1 before you start chemotherapy. These samples will be used for further research into how the drug saracatinib works. This research may not help you but may help other women in the future.

Hospital visits

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

Physical examination
Urine test
Heart trace (ECG)
Blood tests
CT scan or MRI scan
A more detailed (high resolution) CT scan of your chest – your doctor will explain this to you

While you are on the study, you have blood tests every week for the first 6 weeks of each treatment cycle.

In weeks 1, 3 and 6 of each cycle you see the doctor, complete a questionnaire and have a urine test.

You have a CT or MRI scan every 8 weeks, to see how the treatment is working.

When you have completed the study you see the doctors every 6 weeks for 2 years or until your cancer starts to grow again. You have a CT or MRI scan every 3 months or until your cancer starts to grow again.

Side effects

The most common side effects of paclitaxel are

Tiredness (fatigue)
Feeling or being sick
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Hair Loss
Numbness and tingling in hands and feet (peripheral neuropathy)

Saracatinib has similar side effects to paclitaxel but you may also have diarrhoea.

There is more information about paclitaxel on CancerHelp UK.