Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: null- Mestatic Hormone Refractory Prostate Cancer
Conditions
Interventions
Intervention1: Cabazitaxel 25 mg/m²: Cabazitaxel 25 mg/m² intravenously every 3 weeks, in combination with oral prednisolone 10 mg daily for 35 weeks
Control Intervention1: NIL: NIL
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: "Main inclusion criteria: - Age ≥18 years - Metastatic Hormone Refractory Prostate Cancer previously treated with a docetaxel-containing regimen - Disease Progression during or after docetaxel-containing regimen for mHRPC - Surgical or medical castration - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2 - Life-expectancy ≥3 months - Adequate bone marrow, liver, and renal function: Neutrophils 1500 /mm3; Hemoglobin 10 g/dL; Platelets 100 x109/L; Bilirubin ULN; SGOT (AST) 1.5xULN; SGPT (ALT) 1.5xULN; Creatinine 1.5xULN - Signed written informed consent obtained prior to enrollment "
Exclusion criteria
Exclusion criteria: "Main exclusion criteria: - Prior radiotherapy to ≥ 40% of bone marrow - Prior radionuclide therapy (samarium-153, strontium-89, P-32?) - Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment - Active grade ≥2 peripheral neuropathy - Active grade ≥2 stomatitis - Active infection requiring systemic antibiotic or anti-fungal medication - Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years (except superficial non-melanoma skin cancer) - Known brain or leptomeningeal involvement - History of severe hypersensitivity reaction (≥grade 3) to docetaxel - History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs - History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone - Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) - 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) - Participation in a clinical trial with any investigational drug - Patient with reproductive potential not implementing accepted and effective method of contraception "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimenTimepoint: up to 30 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To document safety of cabazitaxel in these patientsTimepoint: 35 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, France, Hungary, India, Iran (Islamic Republic of), Israel, Italy, Luxembourg, Malaysia, Mexico, Philippines, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, United Kingdom
Contacts
Public ContactDr Deepa Chodankar
Sanofi-Aventis
Outcome results
None listed