A study of cediranib and gefitinib for a type of brain tumour called a glioblastoma (DORIC)

Cancer type:

Brain (and spinal cord) tumours

Status:

Results

Phase:

Phase 2

This study compared cediranib and gefitinib with cediranib alone for people with glioblastoma that had come back after treatment.

Cancer Research UK supported this study.

More about this trial

Glioblastoma multiforme is one of the most common types of brain tumours in adults. It can be treated with surgery followed by radiotherapy and a chemotherapy drug called temozolomide.

Unfortunately, glioblastoma often starts to grow again. When this happens, it is very difficult to control and doctors are always trying to find new ways of treating it. In this study, they looked at 2 drugs called cediranib and gefitinib.

Cediranib is a type of biological therapy Open a glossary item called an anti angiogenic drug. It stops cancers from being able to make new blood vessels that are essential for their growth.

Gefitinib is a type of biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The aims of this study were to:

find out if cediranib and gefitinib work better than cediranib alone for glioblastoma that had come back after treatment
learn more about the side effects and how treatment affected quality of life

Summary of results

The study team found that cediranib and gefitinib helped some people in this small study. But it was not clear whether taking this combination was better than cediranib alone.

The team had wanted 112 people to take part in their study. But while this study was happening, a larger phase 3 trial found that cediranib was not better than standard lomustine chemotherapy. So the DORIC study closed early.

The study team published the results they did have from DORIC in 2016.

38 people joined the study. They were put into 1 of 2 groups at random.

19 had cediranib and gefitinib
19 had cediranib and a dummy drug (placebo )

The study team looked at how long people lived for after treatment without their cancer getting worse. This is called progression free survival. This was on average:

just under 4 months (3.6 months) for the people who had cediranib and gefitinib
just under 3 months (2.8 months) for the people who had cediranib and the dummy drug

They also looked at how long people lived for after treatment. This is called overall survival. They found that this was on average:

just over 7 (7.2) months for the people who had cediranib and gefitinib
5 ½ months for the people who had cediranib and the dummy drug

The study team say that not having enough people taking part meant it was difficult to compare the 2 treatments.

Although the above results show a small difference in survival, it was not statistically significant. This means the difference between the 2 groups could have happened by chance.

The research team also looked at quality of life. The results showed that adding gefitinib to cediranib did not affect quality of life.

The most common side effects were tiredness, high blood pressure and a drop in the number of a cell in the blood that fights infection (lymphocytes).

The people having cediranib and gefitinib had more serious side effects. These included:

high blood pressure
weight loss
losing control of body movements (ataxia)

The study team found that although this small study showed that taking cediranib and gefitinib together may work better than taking cediranib alone, the results may be due to chance (not statistically significant).

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.