A prospective phase II trial of cabazitaxel in male patients with chemotherapy pre-treated metastatic non-seminomatous germ-cell tumors - CABA GCT
- Conditions
- patients with pre-treated metastatic and /or primary mediastinal non-seminomatous germ-cell tumorsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000286-36-FR
- Lead Sponsor
- Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
•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 <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
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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; <br>•To evaluate the progression free survival<br>•To evaluate overall survival of patients.<br>•To evaluate the toxicity associated with the treatment regimen;;Primary end point(s): • Favorable response:<br>- Complete response (CR) rate (including cCR, pCR, and sCR)<br>- Partial response rate with negative tumor markers (PRm-) <br>;Timepoint(s) of evaluation of this end point: until progression
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Response rate of brain metastases (RECIST V1.1)<br>•Progression free survival<br>•Overall survival<br>•Toxicity (NCI CTCAE v4.0), including neurotoxicity (patients being pretreated with cisplatin)<br>;Timepoint(s) of evaluation of this end point: until progression