A study looking at cediranib and selumetinib with chemotherapy and radiotherapy for rectal cancer (DREAMtherapy)

Cancer type:

Bowel (colorectal) cancer
Rectal cancer

Status:

Results

Phase:

Phase 1

This study looked at cediranib and selumetinib for rectal cancer that has grown into the area around the rectum (back passage). It was supported by Cancer Research UK.

The trial was open for people to join between 2010 and 2012, and the research team published the results in 2019

More about this trial

Doctors often treat cancer of the rectum with radiotherapy and chemotherapy at the same time, followed by surgery. When you have chemotherapy and radiotherapy together it is called chemoradiotherapy.

The researchers wanted to find out if adding a targeted cancer drug to chemotherapy would make treatment work better.  

The two targeted drugs they looked at were cediranib (AZD2171) and selumetinib (AZD6244). These are both types of cancer growth blockers. They stop the signals that cancer cells use to divide and grow.

The main aims of this trial were to:

  • find the highest dose of each drug that people can have safely at the same time as chemoradiotherapy 
  • see whether either treatment helps stop cancer growing

Summary of results

The research team found that cediranib may be a useful treatment for rectal cancer, but that selumetinib caused too many side effects.

Trial design
The research team ran this as a dual study, looking at two treatments at the same time. It was also what’s called a phase 1 dose escalation study.

The first few people who took part had the lowest dose of cediranib. When they finished treatment, the next few people taking part had selumetinib. And when they finished treatment, the next few people had cediranib again, but at a higher dose. And so on, until they found the best dose of each treatment to give without causing too many side effects.

A total of 30 people joined the study:

  • 18 people had cediranib
  • 12 people had selumetinib

Cediranib results
A total of 18 people had cediranib as part of this trial, in 3 groups. Each group had a different dose.

People who had the highest dose had more severe side effects including diarrhoea and extreme tiredness (fatigue). So the research team concluded that the middle dose was the best dose to use.

The research team looked at how well the treatment worked for 17 of the people who took part. They found that the cancer got smaller in 9 of them (53%). This is higher than expected with standard chemoradiotherapy.

The researchers measured the amount of different proteins in blood samples from those who took part. They found that treatment tended to work better for people with less of a protein called tumour necrosis factor (TNF).

Selumetinib results
A total of 12 people had selumetinib as part of this trial, in 2 groups:

  • 8 people in the first group had a lower dose, twice a day
  • 4 people in the second group had a higher dose, once a day

Some people in both groups had severe side effects such as diarrhoea. And this meant some people needed to have a lower dose of either chemotherapy or radiotherapy than normal. So the research team decided not to continue looking at selumetinib as part of this trial.

When the research team looked at how well the treatment had worked, they found the cancer had got smaller in 2 out of 12 people (17%).

Conclusion
The trial team concluded that:

  • it is possible to run a dual trial in this way
  • cediranib didn’t cause too many side effects and could be a useful treatment for people with locally advanced rectal cancer
  • the level of tumour necrosis factor (TNF) may help predict who will benefit most from treatment 
  • selumetinib caused too many side effects to be a treatment for this group of patients

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

Dr Mark Saunders

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
The Christie NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUKD/10/013.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

6816

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

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