Non-seminomatous Germ-cell Tumors
Conditions
Brief 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.
Interventions
DRUGCabazitaxel
On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
15 Years to No maximum
Healthy volunteers
No
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 (\>/= grade 3) to polysorbate 80 containing drugs or to other taxanes * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments. * Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel. * Active Grade \>/= 3 peripheral neuropathy * Patients who have had a major surgery within 4 last weeks prior enrolment * Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable response | Assessed every 6 weeks from start of treatment up to 72 months | To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate on brain metastases | Assessed every 6 weeks after treatment start up to 72 months | 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 |
| Progression free survival | Assessed every 6 weeks from treatment start to progression up to 72 months | — |
| Overall survival | Assessed every 3 weeks after treatment start up to 72 months | — |
Countries
France
Contacts
STUDY_CHAIRKarim FIZAZI, MD-PhD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed