Informations générales (source: ClinicalTrials.gov)
A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mai 2014
mai 2020
14 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI, MD-PhD | Contact (sur clinicalTrials) | |||
Critères
Homme
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
- 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