Study:
Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel
Rationale:
n/a
Purpose:
Cabazitaxel is already approved by the Food and Drug Administration (FDA) for use in
patients with advanced prostrate cancer, following docetaxel therapy. The purpose of this
study is to better understand the response and toxicity of cabazitaxel of elderly men (age
75 years and older) with advanced prostate cancer who have progressed during or after
treatment with docetaxel. All patients on this study will receive cabazitaxel by intravenous
(through a vein) infusion plus prednisone by mouth twice daily, and following the
chemotherapy infusions, an injection of a granulocyte colony-stimulating factor (G-CSF).
G-CSF will help the body produce more white blood cells, which should help decrease the risk
of getting an infection while being treated with cabazitaxel.
Study Status: Not yet recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Castrate-resistant Metastatic Prostate Cancer |
Drug: Cabazitaxel
Drug: Prednisone
Drug: Granulocyte colony-stimulating factor (G-CSF) |
Phase 2 |
Verified by
Case Comprehensive Cancer Center
December, 2012
Sponsored by: Case Comprehensive Cancer Center
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov identifier: NCT01750866
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195
United States
Dale Shepard, Md, PhD., Principal Investigator