NCT00041236已完成2 期
Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group
European Organisation for Research and Treatment of Cancer - EORTC20 个研究点 分布在 4 个国家目标入组 39 人开始时间: 2002年5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
- 39
- 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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
- Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).
Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed soft tissue sarcoma
- •Malignant fibrous histiocytoma
- •Liposarcoma
- •Rhabdomyosarcoma
- •Synovial sarcoma
- •Malignant paraganglioma
- •Fibrosarcoma
- •Leiomyosarcoma
- •Angiosarcoma including hemangiopericytoma
- •Malignant peripheral nerve sheath tumor
- •Unclassified sarcoma
- •Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
- •The following tumor types are excluded:
- •Gastrointestinal stromal tumor
- •Chondrosarcoma
- •Malignant mesothelioma
- •Neuroblastoma
- •Osteosarcoma
- •Ewing's sarcoma
- •Embryonal rhabdomyosarcoma
- •Prior chemotherapy for metastatic disease required
- •One line of combination chemotherapy containing anthracycline OR
- •No more than 2 single-agent regimens including anthracycline
- •Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
- •Must have 1 measurable lesion
- •Clinical evidence of progression within 6 weeks prior to study
- •Osseous lesions and pleural effusions not considered measurable
- •No known or symptomatic CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.8 mg/dL
- •Albumin at least 2.5 g/dL
- •Creatinine no greater than 1.4 mg/dL OR
- •Creatinine clearance greater than 65 mL/min
- •Cardiovascular:
- •No history of severe cardiovascular disease
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 6 months after study participation
- •No other severe medical illness, including psychosis
- •No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (20)
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