NCT00014313终止2 期
A Phase II Study to Evaluate the Role of Weekly Cisplatin With Oral Etoposide in Ewing's Sarcoma and Primitive Neuroectodermal Tumor (PNET) With Bone and/or Bone Marrow Metatstatic Disease
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2001年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
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 Ewing's sarcoma or primitive neuroectodermal tumor.
详细描述
OBJECTIVES:
- Determine the activity of cisplatin and etoposide in terms of response of patients with metastatic Ewing's sarcoma or primitive neuroectodermal tumor.
- Assess the bone marrow and kidney toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 3 hours on days 1, 8, 15, 29, 36, and 43 and oral etoposide daily on days 1-15 and 29-43 in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 2 years.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Ewing's family tumor as characterized by the following:
- •Positive MIC2 on immunohistochemistry OR
- •Evidence of a chromosomal translocation involving the EWS gene by conventional cytogenetics
- •t(11; 22) translocation or variant OR
- •Demonstration of EWS/FLI1 or EWS/ERG gene fusion by PCR or FISH
- •Metastases outside the lung or pleura
- •At least 1 measurable lesion outside of previously irradiated area
- •No symptomatic or known CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Neutrophil count at least 2,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin less than 3 mg/dL
- •Albumin greater than 2.5 g/dL
- •Creatinine less than 1.2 mg/dL
- •Creatinine clearance greater than 70 mL/min
- •Cardiovascular:
- •No history of uncontrolled cardiovascular disease
- •No other severe medical illness, including psychosis
- •No other prior primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •Not specified
排除标准
- 未提供
研究者
研究点 (1)
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