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Brief Title: Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Official Title: A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy
Study ID: NCT01270880
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Name: Elisabeth Heath
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: PRINCIPAL_INVESTIGATOR