Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT01649635
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.
Secondary Objectives:
* PSA response rate;
* Descriptive assessment of CTC (circulating Tumor Cells);
* Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;
* Description of the Health Quality of Life of the patients;
* Incidence of adverse events.
- Detailed Description
Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cabazitaxel CABAZITAXEL (XRP6258) 25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3 Cabazitaxel Prednisone 25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3 Cabazitaxel G-CSF (Granulocyte colony-stimulating factor) 25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3 Cabazitaxel Ciprofloxacin 25 mg/m2, administered as a 1-hour intravenous infusion, on Day 1 of each cycle, every 21 days Prednisone: 10 mg daily throughout the treatment with cabazitaxel Ciprofloxacin: at a dose of 500 mg for 8 days twice daily (total dose 1.0 g) Granulocyte-Colony Stimulating Factors: maximum dose of 600ug for 7 days or until Absolute Neutrophils Count reaches level ≥ 10.000/mm3
- Primary Outcome Measures
Name Time Method Proportion of patients with some episode of neutropenia classified as grade ≥ 3 21 days
- Secondary Outcome Measures
Name Time Method Proportion of patients with episode of neutropenia grade ≥3 up to 24 months (every 21 days) Rate of febrile neutropenia up to 24 months (every 21 days) Rate of diarrhea grade ≥3 up to 24 months (every 21 days) PSA response rate up to 24 months (every 21 days) Circulating Tumor Cells Count (CTC) rate Day 42, Day 84, Day 126 and End of Treatment Changes from baseline in score derived from the Functional assessment of cancer therapy-prostate (FACT-P) and the Trial Outcome Index (TOI) up to 24 months (every 21 days) Number of patients with adverse events up to 24 months (every 21 days)
Trial Locations
- Locations (6)
Investigational Site Number 006
🇧🇷Lajeado, Brazil
Investigational Site Number 005
🇧🇷Porto Alegre, Brazil
Investigational Site Number 002
🇧🇷São Paulo, Brazil
Investigational Site Number 001
🇧🇷Santo Andre, Brazil
Investigational Site Number 007
🇧🇷Centro, Brazil
Investigational Site Number 004
🇧🇷Curitiba, Brazil