NCT00083005已完成2 期
A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- PSA response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.
详细描述
OBJECTIVES:
Primary
- Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide.
Secondary
- Determine the survival duration in patients treated with this regimen.
- Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.
- Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in these patients.
- Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.
- Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.
- Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.
- Determine the changes in molecular markers of angiogenesis (including, but not limited to, serum and urine vascular endothelial growth factor) in patients before and after treatment with this regimen.
- Determine the toxicity profile of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Metastatic disease
- •Androgen-independent disease
- •Clinically progressive disease documented by at least 1 of the following parameters:
- •Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart
- •PSA ≥ 5.0 ng/mL
- •Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
- •At least 1 new lesion on bone scan
- •Progressive measurable disease
- •Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3*
- •Hemoglobin ≥ 7.5 g/dL* NOTE: *No transfusions within the past 2 weeks
- •AST and ALT < 2.5 times upper limit of normal (ULN)
- •Bilirubin < ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
- •Alkaline phosphatase ≤ 2.5 times ULN OR
- •Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 mg/dL OR
- •Creatinine clearance ≥ 40 mL/min
- •Cardiovascular
- •No transient ischemic attacks or cerebrovascular accident within the past 2 years
- •No myocardial infarction within the past 6 months
- •No uncontrolled congestive heart failure
- •No uncontrolled angina pectoris
- •No thromboembolic disease
- •No peripheral neuropathy ≥ grade 2
- •No cognitive impairment that would preclude study participation or giving informed consent
- •No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
- •Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior thalidomide
- •Chemotherapy
- •No prior docetaxel
- •No prior estramustine
- •No prior chemotherapy for metastatic prostate cancer
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •Recovered from prior radiotherapy
- •See Disease Characteristics
- •Recovered from prior surgery
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
PSA response
Toxicity
次要结局
- Survival
研究者
研究点 (4)
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