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

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00118092

Run by

National Cancer Institute (NCI)

People needed

17

Starts

2005-01-01

Expected to finish

2008-02-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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