17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (tanespimycin)
Patients receive 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of CR.