Clinical trial · Interventional
17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Hormone-Refractory Metastatic Prostate Cancer
NCT00118092CI-TRIAL-00027046completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (tanespimycin)
- description
- Patients receive 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of CR.
- interventionNames
- Drug: tanespimycin
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group
- timeFrame
- Up to 1 year
- description
- Normalization: PSA ≤4.0 ng/ml. This must be confirmed by a second PSA value measured when patient returns in 4-6 weeks. This qualifies as a CR response. \> \> 50% decline: A 50% decline in PSA value from baseline which must be confirmed by a second PSA value measured when patient returns in 4-6 weeks later. This qualifies as a PR response.\> \> Progression: A 25% or greater increase over baseline and an increase in the PSA level by at least 5 ng/mL, which is confirmed by a second value obtained approximately one week later. In addition, radiographic scans are required to confirm that a disease progression is by PSA only.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.