A study to help doctors predict who will respond well to paclitaxel chemotherapy for cancer of the ovary (OXO PCR 01)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at cancer samples, blood samples and scans to see how and why women with certain types of ovarian cancer do or don’t respond to paclitaxel chemotherapy.
More about this trial
If you have cancer of the ovary, you would usually have 2 chemotherapy drugs as part of your 
. One of these drugs is called paclitaxel. Paclitaxel is able to help control the cancer in some patients, but sadly it does not work for everyone. Doctors don’t want to put people through treatment and side effects if it won’t help them.
Researchers in this study want to try and understand why the chemotherapy drugs help some women with ovarian cancer and not others. They will look at cancer samples, blood samples and scans before and after chemotherapy to see what is happening in the cancer.
The aims of this study are to develop a way of working out in future which women are suitable for chemotherapy, particularly paclitaxel treatment, and to develop new treatments for ovarian cancer. The findings from this study will help doctors in future choose the most suitable treatment for each person, so that they can improve treatment outcome and avoid unpleasant side effects for no gain.
You will not have any direct benefit from taking part in this study, but the results of the study will help women with ovarian cancer in the future.
Who can enter
You may be able to enter this study if you are being cared for at the Churchill Hospital, Oxford and
- You have just been diagnosed with a type of ovarian cancer called serous ovarian cancer, or serous fallopian tube cancer, or primary peritoneal cancer
- Your cancer cells look very abnormal under a microscope (they are high grade)
- You have cancer larger than 2cm on the lining of your tummy (abdomen), or have cancer in nearby
lymph nodes or your cancer has spread to the inside of other body organs (stage 3C or 4 ovarian cancer) - You have cancer affecting a sheet of body tissue in your abdomen called the
omentum or the peritoneum that doctors can sample during a scan - You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood tests
- You are willing to use a reliable form of contraception
- You are at least 18 years old
You cannot enter this study if you
- Have another type of cancer (as well as ovarian) which needs treatment
- Have ever had chemotherapy, or radiotherapy to the tummy area (abdomen) or area between your hips (pelvis) for ovarian cancer
- Are still having cancer treatment
- Have a condition that would mean that you couldn’t have chemotherapy, such as an uncontrolled infection, severe liver disease or heart failure – you can check this with your doctor
- Have taken part in a clinical drug trial in the last 28 days (depending on the trial, the doctor running this study may still be happy for you to join this one)
- Have moderate to severe numbness and tingling in your hands or feet (peripheral neuropathy)
- Have hepatitis B, hepatitis C or HIV
- Are pregnant or breastfeeding
- Have any other condition that would make you unwell if you took part, or affect the results of the study
Trial design
In the study there are two groups the
- Tumour Mapping Group
- Single Dose Group
If your doctor says you are able to enter the study, you can decide which group you go in to.
In the Tumour Mapping Group, the researchers will ask for a sample of your cancer from when you have a . You then have the standard treatment of paclitaxel and carboplatin chemotherapy followed by surgery. After surgery the researchers will take some more samples from your cancer that was removed. They will compare these samples with those taken form before treatment.
In addition to the Tumour Mapping Group you may be asked to take part in the Single Dose Group. If you agree to join the Single Dose Group, 3 weeks before you start standard treatment you will have a single dose of paclitaxel chemotherapy. You have paclitaxel through a drip into a vein, over about 3 hours. Before this dose of chemotherapy, you will
- Give the study team some samples of eyebrow hair
- Give a blood sample
- Have a type of scan called an FDG PET scan
For the FDG PET scans, you will need to not eat or drink anything for 6 hours beforehand. The team will put a thin plastic needle (cannula) into a vein in your arm. They will inject the FDG tracer, which will help show things up on the scan more clearly. You then need to rest in a quiet room while the tracer spreads round your body in your bloodstream. You will not feel this.
The next day, you give another sample of eyebrow hair and blood samples. The team will also take samples of your cancer (a biopsy), using a scan to guide the biopsy needle. You have this done under .
You will have another FDG PET scan on the day you start your standard treatment.
Hospital visits
There are no extra hospital visits if you take part in the Tumour Mapping Group.
You make 2 extra hospital visits if taking part in the Single Dose Group
- For the paclitaxel chemotherapy, to give samples and have first FDG PET scan
- For the second set of samples and the biopsy the following day – the procedure will take an hour, and you will stay at the hospital for another hour so that the team can monitor you
The team will pay for your travel costs, but only for the study visits and not those needed as part of your standard care.
Side effects
Common side effects of paclitaxel include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Tiredness (fatigue)
- Feeling or being sick
- Hair loss
- Sore mouth
- Diarrhoea
In the Single Dose Group you have a single extra dose of paclitaxel for the study, a few weeks before you start treatment properly. The team thinks that this single dose is unlikely to cause any more side effects than you would have during the main course of standard treatment with the same drug.
Side effects of biopsies include
- Bruising
- Bleeding
- Pain
- Discomfort
Complications of biopsies can include damage to nearby organs, or bleeding inside, but these are rare.
In the Single Dose Group you will have an injection of FDG PET scan tracer which can very rarely cause an allergic reaction. Staff will be able to treat this if it happens to you. The tracer also contains a small amount of radiation. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The amount of radiation you would have altogether from this study would be similar to about 28 years of background radiation. The team believes this would be very unlikely to affect your health.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Ahmed Ahmed
Supported by
Biomedical Research Council (BRC)
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
National Institute for Health Research (NIHR)
Oncology Clinical Trials Office (OCTO)
University of Oxford
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
