A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (CABA-GCT)

Gustave Roussy

Status and phase

Unknown

Phase 2

Conditions

Non-seminomatous Germ-cell Tumors

Treatments

Drug: Cabazitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02115165

2012/1950 (Other Identifier)

2013-000286-36

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

Male

Ages

15+ years old

Volunteers

No Healthy Volunteers

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