A trial of nab-paclitaxel and gemcitabine for cancer of the pancreas that has spread (SIEGE)

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Cancer type:

Pancreatic cancer

Status:

Results

Phase:

Phase 2

This trial looked at 2 different ways of having nab-paclitaxel and gemcitabine chemotherapy for pancreatic cancer that has spread to another part of the body. 

More about this trial

Nab-paclitaxel (Abraxane) and gemcitabine (Gemzar) are both types of chemotherapy used to treat pancreatic cancer. Nab-paclitaxel is the chemotherapy drug paclitaxel (Taxol) combined with a protein called albumin. 
 
We already knew from research that the combination of nab-paclitaxel and gemcitabine worked better than gemcitabine alone. But researchers wanted to find out more about the best way to give both drugs. 
 
In this trial, they looked at 2 different ways of having nab-paclitaxel and gemcitabine. People taking part either had:
  • both treatments on the same day – this is called concomitant treatment, and was the standard way to have treatment
  • nab-paclitaxel first and then gemcitabine 24 hours later – this is called sequential treatment, and was a new way of having treatment 
Everyone taking part in this trial had cancer that had spread from the pancreas to another part of the body, such as the liver. This is called metastatic pancreatic cancer, or stage 4 pancreatic cancer
 
The aims of the trial were to:
  • see which way of having nab-paclitaxel and gemcitabine works best for pancreatic cancer that has spread
  • learn more about how nab-paclitaxel works

Summary of results

This trial showed that some people who had nab-paclitaxel first and then gemcitabine did better than those who had both drugs on the same day. 
 
Results
This trial recruited 146 people with stage 4 pancreatic cancer that had spread to another part of the body. Everyone taking part had nab-paclitaxel and gemcitabine, and:
  • 75 people had both treatments on the same day (concomitant treatment)
  • 71 people had nab-paclitaxel first and gemcitabine the next day (sequential treatment) 
The research team analysed how well the different treatment plans worked. They looked at how long it was on average, before people’s cancer started to grow again, and found that it was:
  • 4.1 months for people who had the two treatments together
  • 5.8 months for people who had nab-paclitaxel first
They also looked at how long people lived for on average, and it was:
  • 7.9 months for those who had the two treatments together
  • 10.1 months for those who had nab-paclitaxel first
The research team analysed samples of pancreatic cancer from the people taking part in the trial, in the laboratory. They wanted to see if there were any proteins which could help them work out who was most likely to benefit from treatment.
 
They found that 35 people had cancer which produced a lot of a specific protein called cytidine deaminase, or CDA. People in this group who had nab-paclitaxel one day and gemcitabine the next tended to do a bit better than those who had treatment at the same time. But it’s hard to draw firm conclusions as it was quite a small number of people.
 
Side effects 
About 3 in 10 people (28%) in the trial stopped treatment early because of side effects they were having.  The number was similar in the two groups:
  • 20 people who had the two treatments together
  • 21 people who had nab-paclitaxel first
The most common side effects were:
  • a drop in white blood cells, a drop in red blood cells and tiredness, which affected more people who had nab-paclitaxel first and then gemcitabine
  • fever associated with a drop in white blood cells, which affected the same number of people in each group
  • being sick, which affected a few more people who had both treatments at the same time
Although the people who had treatment on different days had more side effects, this didn’t seem to have a negative effect on their quality of life.
 
Conclusion 
The research team concluded that having nab-paclitaxel first and then gemcitabine looked promising for people with pancreatic cancer that had spread. They suggest that it is looked at in further trials in this group of patients.
 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) but may not have been published in a medical journal. The figures we quote above were provided by the research 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 Pippa Corrie

Supported by

Cambridge University Hospitals NHS Foundation Trust 
Celgene 
Experimental Cancer Medicine Centre (ECMC) 
NIHR Clinical Research Network: Cancer 
Cancer Research UK Cambridge Institute 

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Last review date

CRUK internal database number:

11741

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

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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