NCT00064220已完成2 期
A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin.
- Determine the duration of response in patients treated with this drug.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time and 12-month survival rate of patients treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months 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 —（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 of 1 of the following tumor types:
- •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 not eligible:
- •Gastrointestinal stromal tumor
- •Chondrosarcoma
- •Malignant mesothelioma
- •Neuroblastoma
- •Osteosarcoma
- •Ewing's sarcoma
- •Embryonal rhabdomyosarcoma
- •Evidence of disease progression
- •Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease
- •Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed within 12 months of therapy
- •At least 1 measurable lesion with indicator lesions outside of any prior radiation field
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •15 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Bilirubin no greater than 1.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •Ejection fraction at least 40% by MUGA
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No baseline neurotoxicity grade 2 or greater
- •No concurrent serious infection
- •No psychiatric disorder that would preclude giving informed consent or complying with study requirements
- •No other concurrent severe or uncontrolled medical illness that would preclude study participation
- •No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or any other malignancy for which the patient has been in complete remission and off all therapy for at least 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer biologic therapy
- 另有 16 项未显示
排除标准
- 未提供
研究者
研究点 (6)
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