An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
refractory to hormone therapy (received prior castration by orchiectomy and/or internal
medicine, and documented progression of disease or relapse) who has previously been
treated with docetaxel.
I 02. Signed informed consent prior to beginning protocol specific procedures.
I 03. Patients with PSA >20 ng/mL at screening.
E 01. Age <20 and >74
E 02. ECOG performance status ≥2.
E 03. Prior surgery ≤4 weeks of registration in the study.
E 04. Active secondary cancer including prior malignancy from which the patient has been
disease-free for ≤5 years (However, adequately treated superficial basal cell skin cancer
before 4 weeks prior to registration can be eligible to the study)
E 05. Inadequate organ function including:
Neutrophils <2.0 x 109/L Platelets <100 x 109/L Hemoglobin <9.0 g/dL (transfusion
prohibition within 14 days before registration) Creatinine >1.5 mg/dL. Total bilirubin
>1.5 times the upper normal limits of the institutional norms ALT/AST >1.5 times the upper
normal limits of the institutional norms
E 06. Previous treatment with <225 mg/m2 cumulative dose of Taxotere® (or docetaxel).
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.