Phase II Study of Weekly Paclitaxel by 1-HR Infusion Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 28
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES: I. Determine the effect of weekly paclitaxel plus estramustine on PSA response in patients with metastatic hormone-refractory prostate cancer. II. Describe the toxic effects of this treatment in this patient population. III. Determine the effect of treatment on pain, asthenia, and quality of life. IV. Determine the objective response rate after treatment among the patients with bidimensionally measurable disease.
OUTLINE: Patients receive estramustine orally twice a day on days 1-3 of each week for 6 weeks. Patients also receive paclitaxel IV over 1 hour on day 2 of each week for 6 weeks. Courses repeat every 8 weeks in the absence of unacceptable toxicity and disease progression. Quality of life is assessed prior to treatment and at weeks 4, 8, 20, and 24. Patients are followed every 3 months for 2 years, every 6 months for years 2-5, and then annually thereafter.
PROJECTED ACCRUAL: There will be 17-52 patients accrued into this study over 14 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Histologically confirmed metastatic hormone-refractory adenocarcinoma of the prostate gland Elevated serum acid phosphatase or PSA levels must not be only evidence of disease Must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver, or lung metastases) Radiological evidence of hydronephrosis alone does not constitute evidence of metastatic disease Patients with bone metastases only (i.e., lacking measurable soft tissue disease) must have PSA level of at least 20 ng/mL Patients with soft tissue metastases and/or visceral disease must have either bidimensionally measurable disease or a PSA level of at least 20 ng/mL Must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy, LHRH-blocker plus flutamide, etc.) with evidence of treatment failure No carcinomatous meningitis or brain metastases
- •PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Granulocyte count at least 2,000/mm3 Platelet count greater than 100,000/mm3 No history of deep venous thrombosis Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No active angina pectoris No known New York Heart Association class II-IV heart disease No history of myocardial infarction in the last 6 months Other: No history of prior malignancy except if curatively treated and disease free for time period considered appropriate for cure of specific cancer No other serious concurrent illness or active infection Effective contraception required of all fertile patients
- •PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy (including neoadjuvant chemotherapy) Endocrine therapy: See Disease Characteristics At least 6 weeks since prior bicalutamide At least 4 weeks since prior flutamide or nilutamide Recovered from prior toxicities of endocrine therapy Radiotherapy: No prior strontium 89, samarium 153, or other radioisotope therapies At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Recovered from prior surgery
排除标准
- 未提供