A trial looking at trametinib and pazopanib with paclitaxel for melanoma (PACMEL)

Cancer type:

Melanoma
Secondary cancers
Skin cancer

Status:

Results

Phase:

Phase 1/2
This trial looked at 2 drugs called trametinib and pazopanib with paclitaxel chemotherapy in melanoma skin cancer. 
 
It was for people whose melanoma:
  • had spread to nearby lymph nodes Open a glossary item or spread elsewhere in the body (advanced melanoma)
  • couldn’t be removed with surgery
  • cells didn’t have a change in  the gene Open a glossary item called BRAF
Cancer Research UK supported this trial.

More about this trial

Paclitaxel chemotherapy is a possible treatment for melanoma skin cancer that has spread. But it doesn’t always work very well. 

Researchers are looking for ways to improve treatment for people with advanced melanoma. In this trial, they looked at 2 drugs called trametinib and pazopanib. 

Trametinib and pazopanib are both targeted drugs. They are called cancer growth blockers. They work in slightly different ways to stop signals that cancer cells use to divide and grow.

Doctors thought that adding trametinib or pazopanib to paclitaxel chemotherapy might work better than paclitaxel only. But they weren’t sure, so wanted to find out more. 

The main aim of this trial was to find out if trametinib or pazopanib with paclitaxel chemotherapy improved treatment. 

Summary of results

The researchers found that adding trametinib to paclitaxel lengthened the time before the cancer got worse. But it didn’t help people live longer. 
 
This trial was open for people to join between 2012 and 2016. The results were published in 2018.
 
About this trial
This was a phase 2 trial. 111 people joined. They were put into 1 of 3 treatment groups at random by a computer. 
  • 38 people had paclitaxel (group 1)
  • 36 people had paclitaxel and trametinib (group 2)
  • 37 people had paclitaxel and pazopanib (group 3)


Results

After treatment, the trial team looked at how well treatment had worked. They looked at how long people lived before their cancer started to grow again. This is called progression free survival.
 
When compared to paclitaxel only, they found that paclitaxel and trametinib significantly increased the amount of time before people’s cancer got worse. But there was no difference in how long people lived before the cancer started to grow between people who had paclitaxel only and those who had paclitaxel and pazopanib. 
 
They also looked at whose melanoma had got better after treatment (overall response rate). This was:
 
  • 13 out of every 100 people (13%) who had paclitaxel (group 1)
  • 42 out of every 100 people (42%) who had paclitaxel and trametinib (group 2)
  • 22 out of every 100 people (22%) who had paclitaxel and pazopanib (group 3)

The overall response rate showed that paclitaxel and trametinib worked best. 

The researchers also looked at how long people lived after treatment. This is called overall survival. But they didn’t find any difference between the 3 groups.

Side effects

People who had paclitaxel and trametinib or paclitaxel and pazopanib had more severe side effects than people who had paclitaxel only. 
 
The most common side effect of paclitaxel and trametinib was a skin rash.
 
The most common side effects of paclitaxel and pazopanib were:
  • liver changes
  • taste changes
19 out of 37 people (54%) having paclitaxel and pazopanib had to stop treatment early due to side effects. This was mainly due to liver problems. 
 
6 out of 36 people (18%) having paclitaxel and trametinib had to stop trametinib early due to side effects. 
 
1 person who had paclitaxel and pazopanib died from pneumonia. And 1 person died after developing a hole in their bowel that may have been linked to having pazopanib. 
 
Conclusion
The trial team concluded that having paclitaxel and trametinib lengthened the time before the melanoma got worse. But it didn’t lengthen the time people lived. 
 
They also concluded that having paclitaxel and pazopanib didn’t improve treatment compared with paclitaxel on its own. But all trial results help doctors and researchers understand more about different cancers and the best way to treat them.
 
Both trametinib and pazopanib had more serious side effects compared to having paclitaxel on its own. 
 
Where do these results come 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 Mark Middleton

Supported by

Cancer Research UK
GlaxoSmithKline (GSK)
Novartis
University of Oxford
 

 

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Last review date

CRUK internal database number:

8783

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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