A trial of bortezomib with epirubicin, carboplatin and capecitabine chemotherapy for cancer where the food pipe meets the stomach

The trial team found the best dose of bortezomib to give with EcarboX for gastro oesophageal junction cancer.

This was a phase 1 study. It recruited 19 people.

The first few people had a low dose of bortezomib with EcarboX. If they didn’t have any serious side effects, the next few people had a higher dose of bortezomib. And so on until they found the best dose of bortezomib to give with EcarboX. This is called a dose escalation study.

The most common side effects were

• A drop in blood cells causing an increased risk of infection, bruising and bleeding
• Tiredness
• Loss of appetite 
• Feeling or being sick

For 18 of the 19 people, the researchers were able to see how well their cancer had responded. They found that

• In 6 people the cancer had shrunk – partial response  
• In 5 people the cancer had stayed the same size – stable disease
• In 7 people the cancer had continued to grow

The trial team did find the best dose of bortezomib to give with EcarboX.

But they also found that giving bortezomib with EcarboX caused a significant drop in the number of white blood cells causing high temperatures (fevers) due to infection. The team decided to reduce the dose of capecitabine to see if this would help. But it didn’t.

They concluded that the combination of bortezomib and EcarboX shouldn’t be looked at in further trials because it didn’t work any better than EcarboX alone. And it was difficult to give safely because the drop in white blood cells was a significant problem.  

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 ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.