"I now know how cancer can strike anyone whatever their situation or circumstance. I hope by taking part in a trial it will help others in my position in the future.”
A trial looking at chemotherapy for advanced germ cell cancer that has come back (Gem-TIP)
This trial was looking into giving gemcitabine (Gemzar), paclitaxel (Taxol), ifosfamide and cisplatin for advanced germ cell cancer that had come back (relapsed). This combination of chemotherapy is called Gem-TIP.
Doctors often treat germ cell cancers with a combination of chemotherapy called BEP. This is bleomycin, etoposide and cisplatin. But sometimes the cancer starts to grow again. There is no standard second line chemotherapy for advanced germ cell cancer that had come back, but in a recent trial, doctors showed that TIP (paclitaxel, ifosfamide and cisplatin) worked well.
Doctors thought that adding another chemotherapy drug called gemcitabine would make TIP work better. But Gem-TIP is a new drug combination for advanced germ cell cancer so doctors didn’t know how well it would work. They also thought that you may be able to have a higher dose of gemcitabine with TIP if you also had a growth factor called G-CSF. Gem-TIP causes a drop in blood cells in your bone marrow. G-CSF helps your bone marrow to replace your blood cells more quickly.
The aims of the trial were to find out
- The best dose of gemcitabine to give
- How well gemcitabine and TIP work together
- What the side effects are
The results of this study would be helpful for further trials in a larger number of people with advanced germ cell cancer.
Summary of results
The trial team found
- The highest dose of gemcitabine they were able to give with TIP
- The side effects of combining gemcitabine and TIP
They also gained some early information on how well this combination worked.
The trial recruited 13 people. Everyone in the trial had the same dose of TIP. The first few people recruited had a low dose of gemcitabine. As they did not have too many bad side effects, the next few people recruited had a higher dose of gemcitabine. This continued until the last 6 people recruited had the highest dose of gemcitabine. This is called a ‘dose escalation’ study.
The most common side effects with this combination were
- A drop in blood cells causing an increased risk of infection
- Feeling or being sick
- Hair loss
Of the 13 people recruited, 10 people had a scan that showed the effect on their tumour. The results were
- The tumour could not be seen in 5 people
- The tumour had shrunk in 3 people
- The tumour had continued to grow in 2 people
The researchers decided on the best dose of gemcitabine to give with TIP. As the results looked promising, they have taken this research to the next stage (a phase 2 trial) to find out more about giving the chemotherapy combination of Gem-TIP for advanced gem cell cancer that has come back.
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 (
How to join a clinical trial
Dr Ben Mead
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
University Hospital Southampton NHS Foundation Trust