A trial looking at gemcitabine with omega 3 fish oil to treat pancreatic cancer

This trial is looking at using omega 3 fish oil with gemcitabine to treat pancreatic cancer that has started to grow into the surrounding tissues (is locally advanced) or has spread to other parts of the body (is metastatic).

Doctors may use chemotherapy to treat advanced pancreatic cancer. One chemotherapy drug they may use is gemcitabine. Doctors have given gemcitabine with other chemotherapy drugs to try and improve treatment for people with advanced pancreatic cancer, but with little success.

We know from laboratory studies that omega 3 fish oil may slow down the growth of pancreatic cancer cells and increase the rate that the cancer cells self destruct (‘apoptosis’). In other studies researchers have found that gemcitabine worked better against pancreatic cancer cells when patients had omega 3 fish oil at the same time.

The aim of this trial is to find out if giving omega 3 fish oil with gemcitabine can help people with advanced pancreatic cancer.

Recruitment

Start 16/11/2009

End 01/08/2012

Phase

Phase 2

Who can enter

You can enter this trial if

You have the most common type of pancreatic cancer (adenocarcinoma) that has grown into the surrounding tissue (locally advanced) or spread to other parts of the body (metastatic)
Your cancer cannot be removed with surgery
You are able to have gemcitabine
You are fully active and able to look after yourself apart from doing heavy physical work (performance status 0, 1)
You have satisfactory blood test results
You are willing to use reliable contraception, during the treatment and for 6 months after, if there is a chance that you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Have had chemotherapy for pancreatic cancer that has spread to another part of your body or that has grown into the surrounding tissue
Are not able to have gemcitabine
Have had radiotherapy in the last 4 weeks
Have had major surgery in the last 4 weeks
Have had a major injury in the last 4 weeks
Have a high level of fat in your blood (your doctor will test for this)
Have problems with too much fluid in your body
Have problems with bleeding (you may join the trial if you are taking medication to control this)
Have another cancer, unless it has been treated and there has been no sign of it (it is in complete remission) for at least 5 years - you may join the trial if you have carcinoma in situ of the cervix or breast and basal cell or squamous cell skin cancer that has been successfully treated
Are HIV positive
Have another serious medical condition that could affect you taking part in the trial
Are allergic to fish, eggs or soya
Are pregnant

Trial design

This is a phase 2 trial. It will recruit 21 people to start with. If results are promising, it will go on to recruit another 29, giving a total of 50 people in the trial.

Everyone taking part will have gemcitabine and omega 3 fish oil. You have both through a drip into a vein every 4 weeks. Each 4 week period is a cycle of treatment. You have gemcitabine over 30 minutes. You have omega 3 fish oil over 4 hours. You can drink and eat as normal while having treatment.

You have treatment until your cancer starts to grow again or the side effects are too much.

If you agree to take part in the trial the researchers will ask you to fill in a questionnaire. This will ask you about any side effects and how you have being feeling. This is called a quality of life study.

Hospital visits

You will see the doctor and have some tests before taking part in this trial. These tests include

Physical examination
Blood tests
Urine test
Heart trace (ECG)
CT scan

During treatment you see the doctor before each cycle and have a physical examination and blood tests. You also have a blood test at 8 and 15 days of each cycle. You have a CT scan every 8 weeks.

After your last treatment, you see the doctor at 4 weeks and have the following