Testis CAB: Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell Cancer

Inclusion Criteria:

* 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

Exclusion Criteria:

* Systemic antitumor treatment within 21 days before study entry
* Simultaneous radiotherapy to the only target lesion
* Patients unwilling or unable to comply with the protocol
* Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure New York Heart Association (NYHA) III-IV or serious uncontrolled cardiac arrhythmias
* Patients with an active or uncontrolled infection
* Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer
* Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks
* Patients who have participated in another interventional clinical trial within 30 days before study entry
* Other serious medical conditions that could impair the ability of the patient to participate in the study
* Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication
* Neuropathy ≥Grade 2 Common Terminology Criteria for Adverse Events (CTCAE)
* Patient with reproductive potential not implementing accepted and effective method of contraception during the whole study period and up to 6 months after the last dose of cabazitaxel
* One or more of the following cabazitaxel-specific requirements:

  * History of severe hypersensitivity reaction (≥ Grade 3) to docetaxel
  * History of severe hypersensitivity reaction (≥ Grade 3) to polysorbate 80 containing drugs
  * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4) (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
  * Concurrent or planned treatment with Organic anion transporting polypeptide1B1 (OATP1B1) substrates e.g. statins, valsartan, repaglinide which have to be taken within 12 hours before cabazitaxel application and 3 hours after the end of infusion, refer table 9