Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT02441894
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the tolerability of cabazitaxel 25 mg per body surface area (m\^2) with primary prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count \[ANC\] \<1000 per volume \[mm\^3\] and a single temperature of \>38.3 degree or a sustained temperature of ≥38 degree Celsius for more than one hour) during Cycle 1.
Secondary Objective:
To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose delay due to adverse events (AEs); dose reduction due to AEs; relative dose intensity; incidences of FN-related hospitalization and use of intravenous (IV) anti-infectives; tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if available.
- Detailed Description
The total duration of study is 254 days as maximum with 14 days for screening, maximum of 21 days times 10 cycles for treatment, and 30 days for follow up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cabazitaxel PEG-G-CSF 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles. Cabazitaxel Metoclopramide, Granisetron, or Ondansetron 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles. Cabazitaxel Dexamethasone 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles. Cabazitaxel Dexchlorpheniramine or Diphenhydramine 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles. Cabazitaxel CABAZITAXEL XRP6258 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles. Cabazitaxel Ranitidine 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles. Cabazitaxel Prednisolone 25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks. Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles.
- Primary Outcome Measures
Name Time Method Number of patients with FN (all grades) during study Cycle 1 3 weeks (during study Cycle 1)
- Secondary Outcome Measures
Name Time Method Number of patients with Grade ≥3 neutropenia Up to 7 months as treatment period Number of dose delays in the start of drug administration due to AEs Up to 7 months as treatment period Number of dose reductions due to AEs Up to 7 months as treatment period Percent change in relative dose intensity due to AEs Up to 7 months as treatment period Number of patients with FN-related hospitalization Up to 7 months as treatment period Number of patients who used IV anti-infective drugs Up to 7 months as treatment period Changes of PSA levels from baseline Up to 7 months as treatment period Number of patients with adverse events Up to 7 months as treatment period Number of patients with FN (all grades) Up to 7 months as treatment period Number of patients with Grade ≥3 diarrhea Up to 7 months as treatment period
Trial Locations
- Locations (8)
Investigational Site Number 392008
🇯🇵Kita-gun, Japan
Investigational Site Number 392001
🇯🇵Shinjuku-ku, Tokyo, Japan
Investigational Site Number 392004
🇯🇵Chuo-ku, Chiba, Japan
Investigational Site Number 392009
🇯🇵Yokohama-shi, Japan
Investigational Site Number 392007
🇯🇵Kobe-shi, Hyogo, Japan
Investigational Site Number 392006
🇯🇵Osaka Sayama-shi, Osaka, Japan
Investigational Site Number 392005
🇯🇵Nagakute-shi, Aichi, Japan
Investigational Site Number 392002
🇯🇵Yokohama-shi, Kanagawa, Japan