NCT00276692已完成2 期
Phase II Study of Irinotecan (CPT-11) in Children and Adolescents With High Risk Ewing's Sarcoma
Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2003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
- 发起方
- 入组人数
- 35
- 试验地点
- 41
- 主要终点
- Response as measured by MRI following course 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with newly diagnosed Ewing's sarcoma.
详细描述
OBJECTIVES:
Primary
- Assess the responsiveness of single-agent irinotecan hydrochloride in a patient population with newly diagnosed high-risk Ewing's sarcoma.
OUTLINE: This is an open-label, multicenter study.
Patients receive irinotecan hydrochloride IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses. After completion of 2 courses of therapy, patients may receive additional treatment at the discretion of the treating physician.
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
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Ewing's tumor
- •Ewing's sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue
- •High-risk disease (R3), defined as metastases at extrapulmonary/pleural sites
- •Newly diagnosed disease
- •Measurable primary and/or metastatic disease
- •At least one bidimensionally measurable lesion
- •Concurrent enrollment on EURO-Ewing99 clinical trial required
- •PATIENT CHARACTERISTICS:
- •No abnormal cardiac function, including any of the following:
- •Fractional shortening < 29%
- •Ejection fraction < 40%
- •Glomerular filtration rate ≥ 60mL/min
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No prior or current history of chronic diarrhea, bowel obstruction, sub obstruction, Crohn's disease, or ulcerative colitis
- •No other medical, psychiatric, or social condition incompatible with the study treatment
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy
- •No more than 45 days since prior definitive biopsy
排除标准
- 未提供
结局指标
主要结局
Response as measured by MRI following course 2
次要结局
未报告次要终点
研究者
研究点 (41)
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