Status:
COMPLETED
17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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,...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the prostate-specific antigen (PSA) response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin (17-...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00118092
Start Date
January 1 2005
End Date
February 1 2008
Last Update
April 18 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905