Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel
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
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients progression-free survival after completion of treatment.
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.
at end of treatment (up to 30 weeks)
Dale Shepard, Md, PhD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|