Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell
Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer. Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical activity in patients with metastatic and progressive germ cell tumors.
• Male patients ≥ 18 years old
• Histologically verified metastatic germ cell cancer (GCC) of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum
• Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different cisplatin-based regimens
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
• Life expectancy ≥ 3 months
• At baseline adequate function of liver, kidneys and bone marrow:
⁃ ·Neutrophils ≥ 1.5 x 109/L·
• Hemoglobin ≥ 9.0 g/dL
• Platelets ≥ 100 x 109/L
• Creatinine ≤ 1.5 x upper limit of normal (ULN)
• Total Bilirubin ≤ 1.0 x ULN
• Serum glutamate oxaloacetate transaminase (SGOT/AST) ≤ 1.5 x ULN
• Serum glutamate pyruvate transaminase (SGPT/ALT) \< 1.5 x ULN