NCT00006114Unknown2 期
First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
GERCOR - Multidisciplinary Oncology Cooperative Group20 个研究点 分布在 1 个国家开始时间: 1999年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.
- Determine the toxicities of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate
- •Progressive disease despite hormonal therapy or orchiectomy
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 9 g/dL
- •Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone metastasis)
- •Bilirubin less than 2 times ULN
- •Creatinine less than 2 times ULN
- •Cardiovascular:
- •Adequate cardiac function
- •No other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •Prior corticosteroids allowed if started at least 8 weeks prior to study
- •Radiotherapy:
- •At least 8 weeks since prior extensive radiotherapy
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (20)
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