17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: tanespimycin; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well 17-AAG works in treating patients with metastatic
      prostate cancer that did not respond to previous hormone therapy. Drugs used in chemotherapy,
      such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Metastatic disease

          -  Measurable or evaluable disease

               -  Prostate-specific antigen (PSA) ≥ 5 ng/mL OR new areas of bony metastases on bone
                  scan are required for patients with no measurable disease

          -  Objective disease progression OR rising PSA despite receiving androgen deprivation
             therapy and undergoing antiandrogen withdrawal

               -  Patients with a rising PSA must have 2 successive elevations (measured ≥ 1 week
                  apart)

          -  Must be castrate (testosterone < 50 ng/mL)

               -  Luteinizing hormone-releasing hormone agonist therapy must be continued during
                  study participation to maintain castrate levels of testosterone

          -  Must have received ≥ 1 prior chemotherapy regimen for metastatic disease

          -  No known brain metastases requiring active therapy

               -  Previously treated asymptomatic brain metastases allowed

          -  Performance status - ECOG 0-2

          -  At least 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal

          -  Alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal

          -  Creatinine clearance ≥ 60 mL/min

          -  Creatinine normal

          -  QTc < 450 msec for male patients

          -  LVEF > 40% by MUGA

          -  EF normal by MUGA if prior anthracycline therapy

          -  No congenital long QT syndrome

          -  No left bundle branch block

          -  Deep venous thrombosis or other clinically significant thromboembolic event within the
             past 6 months allowed provided patient is clinically stable on anticoagulation therapy

          -  No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or
             ventricular fibrillation ≥ 3 beats in a row)

          -  No myocardial infarction within the past year

          -  No cerebrovascular accident or transient ischemic attack within the past 6 months

          -  No New York Heart Association class III or IV congestive heart failure

          -  No poorly controlled angina

          -  No uncontrolled dysrhythmia or dysrhythmias requiring medication

          -  No active ischemic heart disease within the past 12 months

          -  No other significant cardiac disease

          -  Pulmonary embolus allowed within the past 6 months provided patient is clinically
             stable on anticoagulation therapy

          -  Fertile patients must use effective contraception

          -  Willing and able to provide blood samples

          -  No serious allergy (i.e., hypotension, dyspnea, anaphylaxis, or edema) to eggs

          -  No other concurrent malignancy or history of a curatively treated malignancy with a
             survival prognosis of < 5 years

          -  No known HIV positivity

          -  No active infection

          -  No other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that would preclude study participation

          -  At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide)

          -  At least 28 days since prior radiotherapy

          -  No prior radiotherapy field that included the heart (e.g., mantle)

          -  More than 6 months since prior coronary or peripheral artery bypass grafting

          -  More than 28 days since prior investigational agents for prostate cancer

          -  No concurrent agents that interact with cytochrome P450 3A4

          -  No concurrent warfarin for anticoagulation

               -  Concurrent low molecular weight heparin injection allowed

          -  No concurrent medications that would prolong QTc

          -  No other concurrent antineoplastic agents

          -  Concurrent zoledronate for bone metastases or hypercalcemia allowed