Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs. Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, France
Favorable response
To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
Time frame: Assessed every 6 weeks from start of treatment up to 72 months
Response rate on brain metastases
MRI of the brain every 6 weeks only in case of brain metastases detected at baseline and for all patients at the end of the study. Evaluation will be made using RECIST V1.1
Time frame: Assessed every 6 weeks after treatment start up to 72 months
Progression free survival
Time frame: Assessed every 6 weeks from treatment start to progression up to 72 months
Overall survival
Time frame: Assessed every 3 weeks after treatment start up to 72 months
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