castration-resistant prostate cancer
Conditions
Interventions
Pegfilgrastim by subcutaneous injection within 24-72 hours after Cabazitaxel administration
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Patients had newly diagnosed and histologically confirmed prostate cancer 2.Serum testosterone levels are less than 50ng/dl by castration or by drug 3.All patients included in this study should have castration-resistant prostate cancer after docetaxel treatment failure or sever adverse events. 4.Patients were age 20 years or older 5.Eastern Cooperative Oncology Group performance status of 0-2 6.Life expectancy could be more than three months. 7.Adequate hematologic, hepatic and renal function as follows: Neutrophil count 1,500/mm^3 or higher Haemoglobin level 9.0g/dl or higher Platelet count 100,000/mm^3 or higher Serum Total bilirubin level 1.0x the upper limit of normal or lower Serum aspartate aminotransferase (AST) levels no higher than 1.5 the ULN Serum alanine aminotransferase (ALT) levels no higher than 1.5 the ULN Serum creatinine level no higher than 1.5 the ULN Or Creatinine clearance 50ml/min or higher 8. All patients provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.Bone marrow function falls by the previous treatment by radiation. 2.Patients have a history of radiation therapy by Sm^153 or P^32 within eight weeks after registration, or by Sr^89 or Ra^223 within twelve weeks after registration. 3.Patient who have a history of an operation, radiation or chemotherapy within four weeks after registration. 4.Patients with a peripheral nerve obstacle of grade more than 2. 5.Patients with stomatitis of grade more than 2. 6.Patient with active infection that should be administered antibiotic or anti-fungal agent 7.Patients with other cancers in the past for five years except for early cancer that should be cured. 8.Patients with brain metastasis or meningitis carcinomatosa 9.Patients with a history of hypersensitive reaction to docetaxel, polysorbate80, prednisolone, granulocyte colony-stimulating factor. 10.Patients with a history of serious arrhythmia, angina pectoris, hypertension, diabetes mellitus, congestive heart failure or myocardial infarction within six months. Patients general condition remain unstable even with intensive care. 11.Patients with interstitial pneumonia on chest X-ray. 12.Patients that need a blood transfusion within fourteen day after chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia in the initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia through treatments, Incidence of grade 4 febrile neutropenia through all treatments, The hospitalization frequency dur to febrile neutropenia through all treatments, The use frequency of the antibiotic pill through all treatments, response rate of Cabzitaxel, PFS(progression free survival), overall survival | — |
Countries
Japan
Contacts
Public ContactYukimasa Hatachi
Kobe City Medical Center General Hospital Medical oncology
Outcome results
None listed