Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vasoconstrictor Agents

Respiratory System Agents

Hormones

Docetaxel

Enzyme Inhibitors

Xylometazoline

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.

Hsp90 inhibitor STA-9090

laboratory biomarker analysis

polymerase chain reaction

enzyme-linked immunosorbent assay

RNA analysis

spectrophotometry

reverse transcriptase-polymerase chain reaction

gene expression analysis

Elisabeth Heath

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.

Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

A Phase II Trial of STA-9090 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Based Chemotherapy

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.

Overall safety and tolerability of STA-9090 by total number of grade 3 adverse events

Overall Survival (OS) in metastatic Castrate Resistant Prostate Cancer (CRPC) who have received prior docetaxel therapy using Kaplan-Meier method

Association of PFS with PSA using Cox PH regression model

Potential markers for predicting drug response or efficacy : This is not a measurable outcome, but a possible entity for further study.

National Cancer Institute (NCI)

Barbara Ann Karmanos Cancer Institute

Principal Investigator

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.

Hsp90 inhibitor STA-9090: Given IV

laboratory biomarker analysis: Correlative studies

polymerase chain reaction: Correlative studies

enzyme-linked immunosorbent assay: Correlative studies

RNA analysis: Correlative studies

spectrophotometry: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

gene expression analysis: Correlative studies

Treatment (Enzyme Inhibitor Therapy)

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Elisabeth I. Heath, M.D.

PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy	NCT01270880	Adenocarcinoma ... Hormone-resista... Recurrent Prost... Stage IV Prosta...	Hsp90 inhibitor... laboratory biom... polymerase chai... enzyme-linked i... RNA analysis spectrophotomet... reverse transcr... gene expression...	18 Years -	Barbara Ann Karmanos Cancer Institute
Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy	NCT01270880	Adenocarcinoma ... Hormone-resista... Recurrent Prost... Stage IV Prosta...	Hsp90 inhibitor... laboratory biom... polymerase chai... enzyme-linked i... RNA analysis spectrophotomet... reverse transcr... gene expression...	18 Years -	Barbara Ann Karmanos Cancer Institute

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