Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer
Castrate-resistant Metastatic Prostate Cancer
Drug: Granulocyte colony-stimulating factor (G-CSF)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel|
- Number of patients progression-free survival after completion of treatment. [ Time Frame: at end of treatment (up to 30 weeks) ] [ Designated as safety issue: No ]Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy. Progression-free survival defined as PSA progression, tumor progression in patients with measurable disease, or death.
- Number of patients that experience treatment-emergent adverse events [ Time Frame: at end of each treatment cycle (up to 30 weeks) ] [ Designated as safety issue: Yes ]The assessment of safety will be based on the frequency and severity of adverse events. The incidence of treatment-emergent adverse events will be summarized by organ system, severity based on CTCAE (Common Terminology Criteria for Adverse Events) version 4.02, and relation to study drug by dose cohort. Adverse events assessed after each treatment cycle.
- Number of patients with a prostate-specific antigen (PSA) response [ Time Frame: at end of each treatment cycle (up to 30 weeks) ] [ Designated as safety issue: No ]PSA response defined as a 50% or more reduction in serum PSA concentration in patients with a serum PSA concentration of 20 μg/L or more at baseline and confirmed with a repeat PSA measurement after at least 3 weeks.
- Change in geriatric assessments from baseline to end of therapy [ Time Frame: every 2 cycles of therapy (6 weeks) up to 30 weeks ] [ Designated as safety issue: No ]Geriatric assessment to determine the relationship between functional ability or comorbidity and treatment response or toxicity. Patients will be have a geriatric assessment which will included a range of assessments, such as the Mini Mental Status Exam, Get Up and Go test, and the Geriatric Depression Scale, at baseline and after every 2 cycles of therapy.
- Change in circulating tumor cells (CTC) from baseline [ Time Frame: at end of treatment (up to 30 weeks) ] [ Designated as safety issue: No ]Number of CTC at baseline and after treatment with cabazitaxel
- Change in biomarkers from baseline [ Time Frame: at 3 weeks (after one cycle) ] [ Designated as safety issue: No ]Level H2AX and M30 in CTCs at baseline and after treatment with cabazitaxel
|Study Start Date:||February 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. Treatment will continue until disease progression, intolerable side effects, or a maximum of 10 cycles of therapy.
Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Other Names:Drug: Prednisone
Prednisone 10 mg on Day 1 of the first cycle and continue taking 10 mg po daily for the entire cycle.Drug: Granulocyte colony-stimulating factor (G-CSF)
Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia.
This is a single arm, open label, phase II trial of cabazitaxel every 3 weeks in patients who are ≥ 75 years of age with castration-resistant, metastatic prostate cancer who have progressed during or after docetaxel.
-The primary objective is to determine the efficacy of cabazitaxel in men 75 years of age or older with castration-resistant, metastatic prostate cancer who have progressed during of following treatment with docetaxel.
- To characterize the safety and tolerability of cabazitaxel in patients ≥ 75 years of age
- To determine the PSA response
- To determine the effect of cabazitaxel on functional status using geriatric assessments
- Determine the effect of therapy with cabazitaxel on the number of circulating tumor cells (CTC)
- To measure the effects of cabazitaxel on apoptosis in CTCs from patients ≥ 75 years of age using H2AX and M30 as biomarkers.
- To determine the relationship between geriatric-focused assessment of comorbidity and functional ability and toxicity and response.
Patients will receive cabazitaxel 25 mg/m2 every 3 weeks with 10 mg prednisone daily until progression, intolerance of therapy, or withdrawal of consent. Patients will receive granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia. Patients will be followed for 28 days after discontinuation of therapy or death, whichever occurs first. Patients with serious adverse events at the time of removal from the trial will be followed until the toxicities resolve or are deemed irreversible by the treating physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750866
|Principal Investigator:||Dale Shepard, Md, PhD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|