A trial looking at chemotherapy for advanced cancer of the pancreas (GEM-CAP)

Cancer type:

Pancreatic cancer

Status:

Results

Phase:

Phase 3

This trial compared gemcitabine alone with gemcitabine and capecitabine (Xeloda) for advanced pancreatic cancer. This trial was supported by Cancer Research UK.

Unfortunately, most people with pancreatic cancer cannot have surgery to cure their cancer because it is too advanced when it is diagnosed. Doctors believe that giving chemotherapy helps patients by improving symptoms.

Doctors often use a chemotherapy drug called gemcitabine. In this trial, they wanted to see if having capecitabine chemotherapy tablets alongside gemcitabine helped.

The aim of the trial was to see if having gemcitabine and capecitabine together is better than having gemcitabine alone for advanced cancer of the pancreas.

Summary of results

The trial team found that pancreatic cancer responded to treatment in more people who had both drugs. And more people who had both drugs lived for over a year after treatment.

The trial recruited 533 people

  • 266 people had gemcitabine alone
  • 267 people had gemcitabine and capecitabine

Results from the group of people who had gemcitabine alone showed that

  • In 1 person, all signs of the cancer disappeared – researchers call this a complete response Open a glossary item
  • In 32 people, the cancer got smaller – researchers call this a partial response Open a glossary item
  • In 78 people, the cancer didn’t get bigger or smaller – this is called stable disease Open a glossary item
  • In 52 people, the cancer got worse

In the group of people who had gemcitabine and capecitabine

  • 8 people had a complete response
  • 43 people had a partial response
  • 79 people had stable disease
  • The cancer got worse in 42 people

The average length of time it took before the cancer started growing again was less than 4 months for people who had gemcitabine and just over 5 months for people who had both drugs.

Around 1 in 4 people (24%) who had both drugs lived for more than one year, compared to about 1 in 5 people (22%) who had gemcitabine alone.

The main side effect was a drop in the number of blood cells. This affected slightly more people who had both drugs.

The researchers also looked at the results of this trial together with 2 other similar trials. This is called a meta-analysis. Together, the trials in the meta-analysis provided information about more than 900 people. It showed that a combination of gemcitabine and capecitabine helped people with advanced pancreatic cancer more than gemcitabine alone.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr D. Cunningham
Professor J Neoptolemos
Janet Dunn

Supported by

Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)

Other information

This is Cancer Research UK trial number CRUK/01/008.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 106

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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