NCT00410462Unknown2 期
Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Six-month progression-free survival, in terms of complete response, partial response, or no change
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the activity and safety of brostallicin vs doxorubicin hydrochloride as first-line therapy in patients with relapsed, refractory, or metastatic soft tissue sarcoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating and age(younger than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive brostallicin IV over 10 minutes on day 1.
- Arm II: Patients receive doxorubicin hydrochloride IV over 10 minutes on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed high- or intermediate-grade malignant soft tissue sarcoma* of 1 of the following cellular types:
- •Adipocytic (e.g., liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, not otherwise specified)
- •Fibroblastic (e.g., adult fibrosarcoma, myxofibrosarcoma, or sclerosing epithelioid fibrosarcoma)
- •So-called fibrohistiocytic (e.g., pleomorphic malignant fibrous histiocytoma [MFH], giant cell MFH, or inflammatory MFH)
- •Leiomyosarcoma
- •Malignant glomus tumors
- •Skeletal muscle (e.g., rhabdomyosarcoma, alveolar, or pleomorphic)
- •Vascular (e.g., epithelioid hemangioendothelioma or angiosarcoma)
- •Uncertain differentiation (e.g., synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor [PEComa], or intimal sarcoma)
- •Malignant peripheral nerve sheath tumors
- •Malignant solitary fibrous tumors
- •Undifferentiated soft tissue sarcomas not otherwise specified
- •Other types of sarcoma if approved by the study coordinator NOTE: *Includes malignant tumors of non-organ origin and skin and uterine leiomyosarcoma
- •The following tumor types are excluded:
- •Embryonal rhabdomyosarcoma
- •Chondrosarcoma
- •Osteosarcoma
- •Ewing tumors/primitive neuroectodermal tumor (PNET)
- •Gastrointestinal stromal tumors
- •Dermatofibrosarcoma protuberans
- •Inflammatory myofibroblastic sarcoma
- •Neuroblastoma
- •Malignant mesothelioma
- •Mixed mesodermal tumors of the uterus
- •Relapsed, refractory, and/or metastatic disease incurable by surgery or radiotherapy
- •Measurable disease
- •Must have formalin fixed paraffin-embedded tumor blocks and representative hematoxylin/eosin slides available for histological central review
- •No symptomatic or known CNS metastases
- •PATIENT CHARACTERISTICS:
- •At least 60 years of age OR ≥ 18 years of age if patient is not suitable for intensive combination chemotherapy treatments
- •WHO performance status 0-1
- •Absolute neutrophil count > 2,000/mm³
- •Platelet count > 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine clearance ≥ 60 mL/min
- •No serious cardiac illness within the past 6 months, including, but not limited to the following:
- •History of documented congestive heart failure
- •High-risk uncontrolled arrhythmias
- •Angina pectoris requiring antianginal medication
- •Clinically significant valvular heart disease
- •Evidence of transmural infarction on ECG
- •Poorly-controlled hypertension (e.g., systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
- •Normal 12-lead ECG
- •LVEF normal by MUGA or echocardiogram
- •No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
- •No other serious and/or unstable medical condition, illness, or lab abnormality that would preclude study participation
- •No psychiatric illness or familial, social, or geographical condition that would preclude study compliance
- 另有 14 项未显示
排除标准
- 未提供
结局指标
主要结局
Six-month progression-free survival, in terms of complete response, partial response, or no change
次要结局
- Objective tumor response
- Duration of response
- Overall progression-free survival
- Overall survival
- Safety (CTCAE v 3.0)
研究者
研究点 (1)
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