17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Hormones

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