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

Cancer type:

Oesophageal cancer

Stomach cancer

Status:

Results

Phase:

Phase 1

This trial looked at the drug bortezomib with chemotherapy for cancer that started where the food pipe (oesophagus) meets the stomach (the gastro oesophageal junction) and had spread to another part of the body.

Doctors often treat cancer of the gastro oesophageal junction with chemotherapy and surgery. One type of chemotherapy for this cancer is a combination of drugs called ‘EcarboX’. This is epirubicin, carboplatin and capecitabine (Xeloda). In this trial, doctors wanted to see if adding another drug called bortezomib made EcarboX work better.

Bortezomib is a type of biological therapy called a proteasome inhibitor. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Trials had shown that bortezomib also makes cancer cells more sensitive to some types of chemotherapy.

The aims of this trial were to

Find the best dose of bortezomib to give with EcarboX chemotherapy
Find out how well bortezomib with EcarboX worked for cancer of the gastro oesophageal junction
Learn more about the side effects

Summary of results

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