A trial of chemotherapy with or without dalteparin for advanced pancreatic cancer (FRAGEM)

This trial is looking at gemcitabine with or without the blood thinning drug dalteparin (Fragmin) to see which plan works best to treat advanced pancreatic cancer.

Some cancers release certain chemicals that help the blood to clot, or coagulate. This is called ‘activating the coagulation system’. It increases the risk of a blood clot developing in a blood vessel. The number of people with pancreatic cancer that develop a blood clot is 1 in 4 (25%). This is a higher rate than for any other cancer.

If someone develops a blood clot, they are treated as soon as possible with a drug that will thin the blood (an anti-coagulant). This helps to disperse the clot, and prevent any more forming. But a blood clot can be life threatening, and it is not always possible to get treatment in time.

Doctors think that it may be better to give all patients with advanced pancreatic cancer a daily injection of an anti-coagulant called dalteparin (Fragmin), starting when they begin chemotherapy treatment. Hopefully this will help to stop a clot forming in the first place. But these drugs have side effects too, so doctors are not sure yet which approach is best for patients.

In this trial they will compare gemcitabine and dalteparin together, to gemcitabine alone. The aim of the trial is to see how many patients in each group develop blood clots, and to see if dalteparin can effect how well patients do.

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/04/2003

End 31/12/2008

Phase

Phase 2

Who can enter

You can enter this trial if you

Have stage 3 or 4 pancreatic cancer that has spread to the surrounding area (is ‘locally advanced’) or has spread to another part of the body (metastasised)
Are well enough to take part (performance status 0, 1 or 2)
Have satisfactory blood test results
Are prepared to used reliable contraception if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had a blood clot (venous thromboembolism, or VTE) in the past such as a deep vein thrombosis (DVT)
Have problems with abnormal bleeding (blood in your urine, bleeding from your bowel or a bleeding stomach ulcer, for example)
Have had any other cancer in the past
Have had a small filter put into a main vein to protect you from a blood clot (a vena caval filter device)
Already take medication to thin the blood (an anti coagulant, such as warfarin), aspirin or clopidrogel (Plavix)
Have had a stroke in the last 6 months
Are pregnant or breast feeding

Trial design

This is a randomised trial. It will recruit 120 patients into 2 groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have gemcitabine through a drip into a vein once a week for 7 weeks, then a 2 week rest, and then have treatment once a week for another 3 weeks. So you’ll have chemotherapy for 10 weeks out of 12 altogether. This will take about half an hour each time.

If you are in group 2, you will have gemcitabine as above. You will also have a dalteparin injection under your skin (sub cutaneous injection) every day for 12 weeks. Dalteparin is a type of heparin. It will hopefully help to prevent blood clots forming.

If you are in group 1 and develop a blood clot, you will have standard treatment with anti coagulants. If you are in group 2 and develop problems with abnormal bleeding, the doctors will probably decide to stop the dalteparin.

Hospital visits

You will go to hospital for some tests before you start the trial. These include

Blood tests (including a test to see how long your blood takes to clot)
Urine test
Faecal occult blood (FOB) test
Heart trace (ECG)
CT scan

If your urine test or FOB tests showed there was blood in your urine or your faeces, you will have the tests repeated once a month. You will have blood tests once a month while you are having treatment, and a CT scan every 3 months. How often you see the doctors after your treatment will depend on the local policy at your hospital.

Side effects

The main side effect of dalteparin is that you will bleed and bruise more easily than usual. Occasionally this can be serious, or very rarely life threatening. You will have regular tests to check how quickly your blood clots.

The most common side effects of gemcitabine are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and shortness of breath
Feeling or being sick
Loss of fertility

There is more information about gemcitabine on CancerHelp UK