A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

Exclusion Criteria

• •Less than 21 days since prior treatment with chemotherapy
• •Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone or other new agents.
• •Persistent adverse events from previous cancer therapies \> grade 1 (CTCAE - Version 4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail changes grade 2 is acceptable)
• •ECOG performance status \> 1
• •Known CNS malignancy
• •Within 6 months of randomization:
• •* myocardial infarction,
• •* unstable angina,
• •* angioplasty,
• •* bypass surgery,
• •* stroke,
• •* TIA, or
• •* congestive heart failure NYHA class III or IV
• •Within 3 months prior to randomization:
• •* treatment resistant peptic ulcer disease,
• •* infectious or inflammatory bowel disease,
• •* pulmonary embolism
• •* Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
• •History of hypersensitivity to docetaxel or polysorbate 80
• •Inadequate organ and bone marrow function as evidenced by:
• •* Hemoglobin \< 9.0 g/dL
• •* Absolute neutrophil count \< 1.5 x 109/L,
• •* Platelet count \< 100 x 109/L,
• •* AST/SGOT and/or ALT/SGPT \> 1.5 x ULN;
• •* Total bilirubin \> 1.0 x ULN,
• •* Serum creatinine \> 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \< 60 mL/min should be excluded (http://mdrd.com/ for on-line calculation)
• •Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5. A one week wash out period is necessary for patients who are already on these treatments.
• •Patients with reproductive potential not implementing accepted and effective method of contraception.