A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
- Registration Number
- NCT02115165
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cabazitaxel Cabazitaxel -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 V1.1Progression 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
Trial Locations
- Locations (1)
Gustave Roussy Cancer Campus Grand Paris
🇫🇷Villejuif, Val de Marne, France