A trial looking at ATRA and chemotherapy for pancreatic cancer (STARPAC)

Cancer type:

Pancreatic cancer

Status:

Results

Phase:

Phase 1

This trial looked at a treatment called all-trans retinoic acid (ATRA) for pancreatic cancer. It was for people whose cancer had grown into surrounding tissue or spread to another part of the body.

The trial was open for people to join between 2016 and 2018. The team published the results in 2020.

More about this trial

Doctors often treat pancreatic cancer with chemotherapy. When this trial was done, one combination they used was gemcitabine and nab-paclitaxel (Abraxane). 

Doctors wanted to find out if all-trans retinoic acid (ATRA) could help chemotherapy work better. ATRA is also called tretinoin or Vesinoid. It is similar to vitamin A and was already being used to treat certain types of leukaemia. 

Pancreatic cancer is surrounded by thick scar tissue called stroma. This can stop chemotherapy drugs from reaching the cancer cells. Doctors hoped that ATRA would change these stromal cells. And this would mean the chemotherapy could reach the cancer cells.

The main aims of this trial were to:

  • find the best doses of ATRA, gemcitabine and nab-paclitaxel to use
  • learn more about the side effects

Summary of results

This trial showed that ATRA could be a useful treatment for pancreatic cancer that has grown or spread.

Trial design
This trial was for people with pancreatic cancer that had grown and could not be removed with surgery. The people taking part were due to have chemotherapy. Everyone in the trial had ATRA as well as chemotherapy.

This trial was in two parts.

The first part was dose escalation. They first few people in part 1 had the lowest dose of ATRA and chemotherapy. They didn’t have any serious side effects. So the next few people had a higher dose. And so on, until they found the best combination of doses to give.

The second part of the trial was dose expansion. Everyone in part 2 had the same dose of ATRA and chemotherapy. The research team used the results from part 1 to decide the best doses to use.  

Results
A total of 27 people joined this trial. There were:

  • 17 people in part 1 (dose escalation)
  • 10 people in part 2 (dose expansion)

People in part 1 had one of 4 different combinations of doses. The research team decided that the highest doses were the best one to give. So everyone in part 2 had those doses.

The trial team looked at how long people lived. In particular, they looked at something called the median survival. This means the point at which half the people taking part were living, and half had died.

For people in this trial who had ATRA and chemotherapy, the median survival was nearly a year (11.7 months). This is a few months longer than they would expect for people who just have chemotherapy.

The team also looked at what happened to the stromal cells. They found that ATRA did cause a change in these cells.

Side effects
Everyone taking part had at least 1 side effect. But many of them were mild or didn’t last long.

17 people had a side effect that was more severe. The most common side effects were similar to those caused by chemotherapy alone. These included:

  • changes in blood test results
  • diarrhoea
  • feeling or being sick
  • changes in sensations in hands and feet

The results suggest that ATRA may reduce the side effects of chemotherapy. But it’s difficult to say for sure because this was quite a small trial, and everyone had the same treatment. This would need to be looked at in more detail in a larger trial which compared different treatments.

Biomarkers
The team looked at a number of different proteins and genes in the cancer cells. They wanted to see if there were any links between them and how well treatment worked. These are called biomarkers.

They found 2 biomarkers they think could help decide who would benefit most from ATRA in the future. But more work needs to be done to confirm this.

Conclusion
The trial team concluded that ATRA could be a useful treatment for people with advanced pancreatic cancer. And that it didn’t cause too many side effects.

They suggest other trials are done to find out more about how well it works.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Phase I clinical trial repurposing all-trans retinoic acid as a stromal targeting agent for pancreatic cancer
H Kocher and others
Nature Communications, 2020. Volume 11, article number: 4841.

Where this information comes from    
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) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. 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

Professor Hemant Kocher 
Dr David Propper

Supported by

Medical Research Council (MRC)
Celgene Corporation
NIHR Clinical Research Network: Cancer
Barts Health NHS Trust
Queen Mary University of London

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13611

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

Last reviewed:

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