patients with pre-treated metastatic and /or primary mediastinal non-seminomatous germ-cell tumors
Conditions
Interventions
Trade Name: JEVTANA
Product Name: JEVTANA
Pharmaceutical Form: Concentrate and solvent for solution for infusion
CAS Number: 183133-96-2
Other descriptive name: cabazitaxel
Concentration unit: mg mill
Sponsors
Gustave Roussy
Eligibility
Sex/Gender
Male
Inclusion criteria
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 : oHemoglobin ? 10.0 g/dL oAbsolute neutrophil count ?1.5 x 109/L, oPlatelet count ? 100 x 109/L, •Adequate organ function oSerum creatinine 60 mL/min oAST/SGOT and ALT/SGPT = 1.5 x ULN oBilirubin = 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 Are the trial subjects under 18? yes Number of subjects for this age range: 4 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: •Patients receiving an investigational drug 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated non-seminomatous germ-cell tumors (NSGCT);Secondary Objective: •To evaluate the response rate on brain metastases; •To evaluate the progression free survival •To evaluate overall survival of patients. •To evaluate the toxicity associated with the treatment regimen;;Primary end point(s): • Favorable response: - Complete response (CR) rate (including cCR, pCR, and sCR) - Partial response rate with negative tumor markers (PRm-) ;Timepoint(s) of evaluation of this end point: until progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Response rate of brain metastases (RECIST V1.1) •Progression free survival •Overall survival •Toxicity (NCI CTCAE v4.0), including neurotoxicity (patients being pretreated with cisplatin) ;Timepoint(s) of evaluation of this end point: until progression | — |
Countries
France
Contacts
Public ContactMalia Madaoui
Gustave Roussy
Outcome results
None listed