Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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). OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Given IV
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Medicine nd Denistry of New Jersey
Piscataway, New Jersey, United States
University of Wisconsin Cancer Center Riverview
Wisconsin Rapids, Wisconsin, United States
PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy
Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.
Time frame: At 6 months
Percentage Change in PSA
Percentage change in PSA from baseline.
Time frame: From baseline to 12 weeks
Overall Safety and Tolerability of STA-9090
Overall safety and tolerability of STA-9090 by total number of grade 3 adverse events
Time frame: Day 1, 8, and 15 of each course and at end of treatment
OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy
Overall Survival (OS) in metastatic Castrate Resistant Prostate Cancer (CRPC) who have received prior docetaxel therapy using Kaplan-Meier method
Time frame: From first dose to death or the date last known alive
Association of PFS With PSA
Association of PFS with PSA using Cox PH regression model
Time frame: At 6 months
Potential Markers for Predicting Drug Response or Efficacy
Potential markers for predicting drug response or efficacy : This is not a measurable outcome, but a possible entity for further study.
Time frame: At baseline, day 1 of course 3, and end of treatment
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