A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (NCT02115165) | Clinical Trial Compass
CompletedPhase 2
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
France34 participantsStarted 2014-07-23
Plain-language summary
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.
Who can participate
Age range15 Years
SexMALE
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Inclusion Criteria:
* Male patients aged 15 years or older
* Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation
* Primary site located in either the testis, the retroperitoneum or the mediastinum
* Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I)
* In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents
* No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin
* Life expectancy \>/= 3 months
* Adequate hematologic function :
* Hemoglobin \>/= 10.0 g/dL
* Absolute neutrophil count \>/= 1.5 x 10 \^ 9/L,
* Platelet count \>/= 100 x 10 \^ 9/L,
* Adequate organ function
* Serum creatinine \< 1.5 x ULN. If serum creatinine 1.0 - 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) \> 60 mL/min
* AST/SGOT and ALT/SGPT \</= 1.5 x ULN
* Bilirubin \</= 1.5 x ULN
* Information delivered to patient and informed consent form signed by the patient or his legal representative
* Patient affiliated to a social security system or beneficiary of the same
Exclusion Criteria:
* Patients receiving anti cancer therapy within 4 weeks prior to enrolment
* Previous radiotherapy within 4 weeks prior to enrolment
* Serious uncontrolled concurrent medical illness
* History of severe hypersensitivity reaction…
What they're measuring
1
Favorable response
Timeframe: Assessed every 6 weeks from start of treatment up to 72 months