NCT00027781已完成2 期
Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
European Organisation for Research and Treatment of Cancer - EORTC20 个研究点 分布在 6 个国家目标入组 37 人开始时间: 2001年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 20
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.
PURPOSE: Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate.
- Determine the rate and duration of objective PSA response in patients treated with this drug.
- Determine the clinical response rate in patients with measurable disease treated with this drug.
- Determine the acute side effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Beginning within 2 weeks after the last PSA measurement, patients receive MEN-10755 IV over 30 minutes on day 1. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response continue to receive additional courses. Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator.
Patients are followed every 6 weeks until disease progression or initiation of a new therapy.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed hormone-refractory adenocarcinoma of the prostate
- •Disease progression while on prior luteinizing hormone-releasing hormone (LHRH) analogues or after orchiectomy and antiandrogens, given concurrently or consecutively
- •Disease progression is defined as PSA progression documented by increases in PSA recorded at 2 consecutive measurements over a prior reference value
- •Interval of at least 1 week between the reference value and the first of these two PSA increases
- •Continued elevation of PSA for at least 6 weeks after discontinuation of antiandrogens
- •Last PSA value at least 5 ng/mL (Hybritech equivalent)
- •Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist therapy if no prior surgical castration
- •No symptomatic brain or leptomeningeal metastatic disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.7 mg/dL
- •No uncontrolled hypercalcemia
- •Cardiovascular:
- •No history of severe heart disease
- •No myocardial infarction within the past 6 months
- •No cardiac insufficiency
- •Normal cardiac function by MUGA scan and 12-lead EKG
- •No other prior or concurrent malignancy except basal cell or squamous cell skin cancer
- •No uncontrolled systemic nonmalignant disease or infection
- •No psychological, familial, or geographical conditions that would preclude compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •No prior hormonal therapy except estramustine
- •No concurrent estramustine
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy (e.g., for painful bone metastases)
- •See Disease Characteristics
- •No other concurrent experimental drugs or investigational therapy
排除标准
- 未提供
研究者
研究点 (20)
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