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Phase 2 Completed N=17 Treatment

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

Prostate Cancer · Recurrent Prostate Cancer · Stage IV Prostate Cancer
Source: ClinicalTrials.gov NCT00118092 ↗
Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Feb 2017
Primary outcomePrimary: PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group — 0 participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group
SECONDARY
Proportion of Overall Responses
SECONDARY
Overall Survival
9.4
SECONDARY
Disease-free Survival
1.8
SECONDARY
Duration of PSA Response and PSA Control

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00118092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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