Phase 2
Completed N=17
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
| Outcome | Result | p-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
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.