A trial looking at a short, intensive course of chemotherapy for ovarian cancer

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 2

This trial for ovarian cancer was looking at different doses of gemcitabine, in combination with paclitaxel and carboplatin, followed by an infusion of your own blood stem cells.

Doctors often treat advanced ovarian cancer with chemotherapy. Carboplatin and paclitaxel are the 2 drugs doctors most commonly use. You usually have these drugs in 3 week cycles of treatment. In this trial, the researchers wanted to see if having the drugs in 10 day cycles of treatment and adding a drug called gemcitabine was possible.

They also wanted to find the highest dose of gemcitabine that could be safely given without causing too many side effects. This is called a dose escalation study Open a glossary item .

High doses of chemotherapy bring about a drop in the number of white blood cells, causing an increased risk of infection. The women taking part in this trial had a drug called G-CSF to boost the number of blood stem cells after each chemotherapy treatment. After having G-CSF for 8 days, the doctors collected a unit of the patient’s blood. Then, one day later, following the next cycle of chemotherapy, they had their stem cells back through a drip (reinfusion). This helped to replace the blood cells that were damaged by chemotherapy.

The aims of the trial were to

Find the best dose of gemcitabine to use with carboplatin and paclitaxel in 10 day cycles of treatment with stem cell reinfusion
See if this treatment was possible for women with advanced ovarian cancer

Summary of results

The trial team found that it was possible to give chemotherapy, G-CSF and blood stem cells in 10 day cycles of treatment. The number of white blood cells was maintained, but the number of platelets Open a glossary item dropped too low, leading to an unacceptable risk of bleeding. The dose of gemcitabine could not be increased too much, because it caused liver damage at the highest dose used in this trial. So the trial team don’t recommend that this way of giving treatment is used.

The trial recruited 17 women with advanced ovarian cancer

13 women completed 6 cycles of treatment
3 women stopped treatment early because of side effects
1 woman stopped treatment early because her cancer got bigger
In 6 women, the cancer disappeared – researchers call this a complete response
In 7 women, the cancer got smaller – researchers call this a partial response
In 3 women, the cancer stayed the same size – researchers call this stable disease

As well as low platelets and liver damage in women having the highest dose of gemcitabine, other side effects included tiredness and shortness of breath.

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.