Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: Hsp90 inhibitor STA-9090
Other: laboratory biomarker analysis
Genetic: polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Genetic: RNA analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: gene expression analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy|
- PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy [ Time Frame: At 6 months ] [ Designated as safety issue: No ]Defined as the time from first dose until the patient demonstrates disease progression based on PSA changes, discontinues STA-9090 therapy (for any reason), or expires (from any cause), whichever occurs first. Estimated with the standard Kaplan-Meier (K-M) method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived.
- Percentage Change in PSA [ Time Frame: From baseline to 12 weeks ] [ Designated as safety issue: No ]
- Overall Safety and Tolerability of STA-9090 [ Time Frame: Day 1, 8, and 15 of each course and at end of treatment ] [ Designated as safety issue: Yes ]
- OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy [ Time Frame: From first dose to death or the date last known alive ] [ Designated as safety issue: No ]
- Association of PFS and PSA Response Rate With Primary and Secondary Target Markers [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Potential Markers for Predicting Drug Response or Efficacy [ Time Frame: At baseline, day 1 of course 3, and end of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Hsp90 inhibitor STA-9090
Other Name: STA-9090Other: laboratory biomarker analysis
Correlative studiesGenetic: polymerase chain reaction
Other Name: PCROther: enzyme-linked immunosorbent assay
Other Name: ELISAGenetic: RNA analysis
Correlative studiesOther: spectrophotometry
Correlative studiesGenetic: reverse transcriptase-polymerase chain reaction
Other Name: RT-PCRGenetic: gene expression analysis
I. To evaluate progression-free survival (PFS) achieved with STA-9090 (Hsp90 inhibitor STA-9090) in men with castration-resistant prostate cancer (CRPC) who have received prior docetaxel based therapy.
I. To assess the percentage change in prostate-specific antigen (PSA) from baseline to 12 weeks.
II. To assess overall safety and tolerability of STA-9090. III. To evaluate overall survival (OS) outcome in metastatic CRPC who have received prior docetaxel therapy.
IV. To investigate the association of progression-free survival (PFS) and PSA response rate with primary and secondary target markers.
I. To evaluate potential markers for predicting drug response or efficacy, blood samples will be used to collect the serum and extract messenger ribonucleic acid (mRNA) from mononuclear cells and analyzed by quantitative real-time polymerase chain reaction (PCR) and/or enzyme-linked immunosorbent assay (ELISA).
Patients receive Hsp90 inhibitor STA-9090 intravenously (IV) over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270880
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New Jersey|
|University of Medicine nd Denistry of New Jersey|
|Piscataway, New Jersey, United States, 08854|
|United States, Wisconsin|
|University of Wisconsin Cancer Center Riverview|
|Wisconsin Rapids, Wisconsin, United States, 54494|
|Principal Investigator:||Elisabeth Heath||Barbara Ann Karmanos Cancer Institute|