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

This is an interventional treatment trial for Testicular Cancer focused on measuring testicular cancer, cisplatin resistancy Read More

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