castration resistant prostate cancer(CRPC)
Conditions
Interventions
Patients will receive cabazitaxel at a dose of 25 mg/m2 intravenously every 3 weeks in 1 hour. In addition, patients will receive oral prednisolone 10 mg daily throughout the cycle.
Sponsors
National Cancer Center Hospital Exploratory Oncology Research &Clinical Trial Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age 20 or over 2)Castration resistant prostate cancer (CRPC) previously treated with a docetaxel-containing regimen 3) Surgical or medical castration 4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2 5) Life-expectancy >= 3 months 6) Adequate bone marrow, liver, and renal function: Neutrophils > 1500 /mm3; Hemoglobin > 9.0 g /dL; Platelets > 100 x10^9/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5XULN. 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. 7) Signed written informed consent obtained prior to enrollment
Exclusion criteria
Exclusion criteria: 1)Prior radiotherapy to >= 40% of bone marrow 2)Prior surgery, radiation or chemotherapy within 4 weeks prior to enrolment (this 4-week wash-out period is aimed to allow the patient to recover from any side effects of previous therapy) 3)Active grade >=2 peripheral neuropathy 4)Active grade >=2 stomatitis 5)Active infection requiring systemic antibiotic or anti-fungal medication 6)Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for within 5 years (except superficial non-melanoma skin cancer) 7)Known brain or leptomeningeal involvement 8)History of severe hypersensitivity reaction (>=grade 3) to docetaxel 9)History of severe hypersensitivity reaction (>=grade 3) to cabazitaxel 10)History of severe hypersensitivity reaction (>=grade 3) to polysorbate 80 containing drugs 11)History of severe hypersensitivity reaction (>=grade 3) or intolerance to prednisolone 12)Uncontrolled severe illness or medical condition (including uncontrolled cardiac arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of congestive heart failure or myocardial infarction within last 6 months is also not allowed. 13)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) 14)Treatment with any investigational drug within 4 weeks prior to enrolment 15)Patient with reproductive potential not implementing accepted and effective method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data collected for the assessment of safety: - Number of cycles, cumulative dose received, and reason for End of Treatment (EOT) - Adverse Events (AEs), Serious Adverse Events (SAEs) Data collected for the assessment of efficacy - Prostate specific antigen (PSA), Tumor response according to RECIST, TTF, OS | — |
Countries
Japan
Contacts
Public ContactNobuaki Matsubara
National Cancer Center Hospital Eas Department of Breast and Medical Oncology
Outcome results
None listed