Clinical trial NCT02115165: A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
Official title: A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-seminomatous Germ-cell Tumors
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2014-04-15
Enrollment: 34
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 :
* 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

Primary outcomes:
measure: Favorable response
timeFrame: Assessed every 6 weeks from start of treatment up to 72 months
Secondary outcomes:
measure: Response rate on brain metastases
timeFrame: Assessed every 6 weeks after treatment start up to 72 months
measure: Progression free survival
timeFrame: Assessed every 6 weeks from treatment start to progression up to 72 months
measure: Overall survival
timeFrame: Assessed every 3 weeks after treatment start up to 72 months
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val de Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim FIZAZI, MD-PhD
role: STUDY_CHAIR
References: