A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients With Hormone-Refractory Metastatic Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group
研究概览
简要总结
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.
详细描述
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-AAG).
SECONDARY OBJECTIVES:
I. Determine the overall survival and disease-free survival rate in patients treated with this drug.
II. Determine the safety profile of this drug in these patients. III. Determine the duration of PSA response and PSA control in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- 另有 4 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (tanespimycin)
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.
干预措施: tanespimycin (Drug)
Treatment (tanespimycin)
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.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group
时间窗: Up to 1 year
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.
次要结局
- Proportion of Overall Responses(Up to 3 years)
- Disease-free Survival(From registration to documentation of disease progression, assessed up to 3 years)
- Overall Survival(From registration to death due to any cause, assessed up to 3 years)
- Duration of PSA Response and PSA Control(From PSA response to time of progression, assessed up to 1 year)