This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) previously treated with docetaxel containing regimen.
Conditions
Interventions
Trade Name: JEVTANA
Product Name: Cabazitaxel
Product Code: XRP6258
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 183133-96-2
Other descriptive name: CABAZITAXEL
Sponsors
Tampere University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Metastatic castration resistant prostate cancer - Disease progression during or after docetaxel-containing regimen for mCRPC - Surgical or medical castration - WHO performance status 18 years - Adequate bone marrow, liver and renal functions: Hematology: - neutrophils > 1.5 x 109/ l - hemoglobin > 100 g/l - platelets > 100 x 109/l Hepatic function: - total bilirubin 6 x UNL is accepted Renal function: -Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment - Prior therapy with radioisotopes - Other malignant disease/ malignancy (except superficial non-melanoma skin cancer) within the past 5 years - Serious liver disease - History of severe hypersensitivity reaction (grade > 3) to polysorbate 80 containing drugs - 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 already are on these treatments) - Other serious illness or medical condition: (a) Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months (b) Active infection (c) Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use of corticosteroids (d) Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis) (e) Active grade > 2 polyneuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of cabazitaxel administered every second week (biweekly);Secondary Objective: To evaluate: - Time to treatment failure - Response rate - Overall survival - Quality of life;Primary end point(s): Safety ;Timepoint(s) of evaluation of this end point: will be measured by using CTC-AE Version 4.0 common toxicity criteria every second week laboratory values every week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to treatment failure - progression in PSA - progression of evaluable or measurable metastases - unacceptable toxicity - patients´ refusal to continue treatment - death Response rate Quality of life (QoL) Overall survival;Timepoint(s) of evaluation of this end point: PSA and QoL every 6th week and tumour evaluation every 12th week | — |
Countries
Finland
Outcome results
None listed