NCT00014599已完成2 期
Phase II Clinical Trial On Taxol As Single Agent In Locally Advanced And/Or Metastatic Or Recurrent Vulva Cancer Not Amenable For Surgery And/Or Radiotherapy
European Organisation for Research and Treatment of Cancer - EORTC28 个研究点 分布在 6 个国家目标入组 31 人开始时间: 2001年2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
- 31
- 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.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of paclitaxel in patients with locally advanced, metastatic, or recurrent squamous cell carcinoma of the vulva.
- Determine the objective response rate and duration of response in these patients treated with this drug.
- Determine the acute side effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for a maximum of 10 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 9 weeks.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the vulva
- •Not suitable for radiotherapy or surgery as first-line treatment
- •Measurable or evaluable disease
- •At least 1 bidimensionally measurable target lesion
- •Measurable metastatic disease outside previously irradiated areas OR
- •Local recurrence within a previously treated area OR
- •Local lesions showing progression while on treatment
- •No brain metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 1.5 mg/dL
- •AST/ALT less than 2 times upper limit of normal
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No prior or concurrent cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmia requiring medication, or 2nd or 3rd degree heart block)
- •No peripheral neuropathy greater than grade 1
- •No serious active infection
- •No prior allergic reaction to drugs containing Cremophor EL
- •No other serious medical, psychological, familial, or social condition that would preclude study
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy except as concurrent therapy with radiotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •See Chemotherapy
- •No concurrent radiotherapy
- •Not specified
排除标准
- 未提供
研究者
研究点 (28)
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