NCT00041249已完成2 期
Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
European Organisation for Research and Treatment of Cancer - EORTC16 个研究点 分布在 5 个国家目标入组 64 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
- 64
- 试验地点
- 16
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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
详细描述
OBJECTIVES:
- Determine the antitumor activity of brostallicin, in terms of objective response, in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment.
- Determine the time to progression and duration of response in patients treated with this drug.
- Determine the safety and toxic effects of this drug in these patients.
- Correlate clinical outcome with whole blood glutathione level in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors other than gastrointestinal stromal tumor (GIST) vs GIST).
Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 —（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 that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
- •Stratum I
- •Malignant fibrous histiocytoma
- •Liposarcoma
- •Rhabdomyosarcoma
- •Synovial sarcoma
- •Malignant paraganglioma
- •Fibrosarcoma
- •Leiomyosarcoma
- •Angiosarcoma including hemangiopericytoma
- •Malignant peripheral nerve sheath tumor
- •Unclassified sarcoma
- •Miscellaneous sarcoma
- •Stratum II
- •Gastrointestinal stromal tumor
- •Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression
- •The following sarcoma types are excluded:
- •Mixed mesodermal tumors of the uterus (and carcinosarcoma)
- •Chondrosarcoma
- •Malignant mesothelioma
- •Neuroblastoma
- •Osteosarcoma
- •Ewing's sarcoma
- •Embryonal rhabdomyosarcoma
- •At least one measurable lesion
- •Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease
- •Clinical evidence of progression within 6 weeks prior to study treatment
- •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 1.25 times upper limit of normal (ULN)
- •SGPT and SGOT no greater than 3 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.4 mg/dL OR
- •Creatinine clearance greater than 65 mL/min
- •Cardiovascular:
- •No prior severe cardiovascular disease
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for up to 6 months after study
- •No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- •No other severe medical illness
- •No psychosis
- •PRIOR CONCURRENT THERAPY:
- 另有 21 项未显示
排除标准
- 未提供
研究者
研究点 (16)
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