Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Condition: Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 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
Intervention description: Given IV; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed diagnosis of prostate adenocarcinoma with metastasis and
             objective progression or rising PSA despite androgen deprivation therapy and
             antiandrogen withdrawal when applicable

          -  Progression after docetaxel based chemotherapy is needed as follows:

          -  a) If measurable disease present, then either rising PSA, increase in size of the
             lesion/s or both should be present

          -  b) Patients with rising PSA only as progression must demonstrate a rising trend with 2
             successive elevations at minimum intervals of 1 week; a minimum PSA of 5 ng/ml, or new
             areas of bony metastases on bone scan are required for patients with no measurable
             disease; no minimum PSA requirement for patients with measurable disease

          -  Patients should have received at least one prior docetaxel based regimen for
             metastatic disease; no maximum prior therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2

          -  Life expectancy of at least 3 months

          -  Prior radiation therapy or chemotherapy completed at least 28 days prior to enrollment

          -  All patients must be documented to be castrate with a testosterone level =< 0.5 ng/ml;
             luteinizing-hormone-releasing hormone (LHRH) agonist therapy must be continued, if
             required to maintain castrate levels of testosterone; patients must be off
             antiandrogens for a minimum of 4 weeks for flutamide and 6 weeks for bicalutamide or
             nilutamide

          -  Absolute neutrophil count >= 1,500 cells/uL

          -  Platelets >= 100,000/uL

          -  Hemoglobin >= 9.0 g/dL

          -  Serum creatinine =< 1.5 x upper limit of normal (ULN); Note: if serum creatinine is >
             1.5 x ULN, subject is eligible if the calculated creatinine clearance (CLcr) is >= 50
             mL/min

          -  Total bilirubin =< 1.5 x ULN

          -  For patients without documented bone metastases or for patients with liver metastases:
             transaminases (aspartate aminotransferase [AST]/serum glutamic oxaloacetic
             transaminase [SGOT] and/or alanine aminotransferase (ALT)/serum glutamic pyruvic
             transaminase [SGPT]) may be up to 2.5 x institutional ULN if alkaline phosphatase is
             =< ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are =< ULN

          -  For patients with documented bone metastases, the transaminases (AST/SGOT and/or
             ALT/SGPT) should be less than 2.5 x institutional ULN, without regard to the alkaline
             phosphatase level

          -  Sexually active males must use measures to prevent pregnancy in their partners while
             on STA-9090

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Major surgery within 4 weeks prior to first dose of STA-9090

          -  Poor venous access for study drug administration or would require a peripheral or
             central indwelling catheter for study drug administration; study drug administration
             via indwelling catheters is prohibited at this time

          -  Use of any chemotherapy or other standard systemic treatments for prostate cancer,
             including investigational agents within 2 weeks or 6 half- lives of the agent,
             whichever is shorter, prior to receiving STA-9090; there must be at least 2 weeks
             between the end of palliative radiation and the start of study drug and all radiation
             therapy (XRT)-associated toxicities resolved to Grade 1 or 0

          -  History of severe allergic or hypersensitivity reactions to excipients (e.g.,
             Polyethylene glycol [PEG] 300 and Polysorbate 80 [i.e. docetaxel])

          -  Baseline QTc > 450 msec or previous history of QT prolongation while taking other
             medications

          -  Ventricular ejection fraction (Ef) =< 55% at baseline

          -  Any history of current coronary artery disease, myocardial infarction, angina
             pectoris, angioplasty or coronary bypass surgery

          -  History of current uncontrolled dysrhythmias, or requirement for antiarrhythmic
             medications, or Grade 2 or greater left bundle branch block

          -  New York Heart Association class II/III/IV congestive heart failure with a history of
             dyspnea, orthopnea, or edema that requires current treatment with angiotensin
             converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or
             diuretics

          -  Current or prior radiation therapy to the left hemithorax

          -  Treatment with chronic immunosuppressants (e.g. cyclosporine following
             transplantation)

          -  Uncontrolled intercurrent illness including, but not limited to, human
             immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral
             therapy, ongoing or active infection, symptomatic congestive heart failure, unstable
             angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that
             would limit compliance with study requirements

          -  Other medications, or severe acute/chronic medical or psychiatric condition, or
             laboratory abnormality that may increase the risk associated with study participation
             or study drug administration, or may interfere with the interpretation of study
             results, and in the judgment of the investigator would make the subject inappropriate
             for entry into this study