A Phase I Study of Estramustine, Taxotere and Carboplatin (ETP) in Patients With Horomone Refractory Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 4
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 I trial to study the effectiveness of estramustine, docetaxel, and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer.
- Determine the safety and efficacy of this regimen in this patient population.
OUTLINE: This is a dose escalation study of docetaxel.
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3. Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only. Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity.
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 85 Years（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
- •Disease progression following androgen ablation therapy (hormonal or surgical) by either:
- •Increase in the product of bidimensional diameters of 1 or more radiographically documented sites of measurable disease OR
- •Two consecutive increases in PSA documented over a previous reference value
- •First increase in PSA should occur a minimum of 1 week from the reference value and be confirmed
- •First PSA value is less than the previous value, then patient is eligible provided next PSA is greater than the second PSA
- •Testosterone levels documented in the castrate range (i.e., less than 30 ng/mL)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •CALGB 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin normal
- •SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR
- •Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR
- •SGOT no greater than 1.5 times ULN and alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No myocardial infarction within past year
- •No significant change in anginal pattern within past 6 months
- •No New York Heart Association class II-IV heart disease
- •No deep venous thrombosis within past year
- •No significant peripheral neuropathy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior chemotherapy allowed except taxanes or platinum derivatives
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 4 weeks since prior antiandrogens
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
排除标准
- 未提供