NCT00104949已完成2 期
Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Response rate (confirmed complete response and partial response)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate (confirmed complete response and partial response) in patients with HER2/neu-overexpressing locally advanced or metastatic synovial sarcoma treated with trastuzumab (Herceptin^®).
Secondary
- Determine the frequency and severity of toxic effects of this drug in these patients.
- Determine overall survival and progression-free survival of patients treated with this drug.
- Correlate, preliminarily, SYT-SSX translocation, HER2/neu expression, and monophasic and biphasic phenotype with clinical outcomes in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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 confirmed synovial sarcoma meeting 1 of the following stage criteria:
- •Locally advanced disease, defined as 1 of the following:
- •Incurable by conventional multidisciplinary therapy, including surgery
- •Surgically resectable only with significant morbidity
- •Metastatic disease
- •Tumor HER2/neu positive (2+ or 3+) by immunohistochemistry
- •Tumor tissue must be available AND patient must be willing to allow specimen submission
- •Measurable disease
- •No known CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Hemoglobin > 8 g/dL
- •Platelet count > 100,000/mm^3
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •SGOT and/or SGPT < 1.5 times ULN (5 times ULN if liver metastases are present)
- •Creatinine < 1.5 times ULN OR
- •Creatinine clearance > 60 mL/min
- •Cardiovascular
- •LVEF > 45% by MUGA
- •Gastrointestinal
- •No active peptic ulcer disease
- •No active gastrointestinal bleeding
- •No active inflammatory bowel disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No known HIV positivity
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent filgrastim (G-CSF)
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 60 days since prior radiotherapy to the target lesion*
- •No concurrent radiotherapy NOTE: *Lesion must have demonstrated disease progression after completion of therapy
- •At least 21 days since prior major surgery and recovered
- •At least 60 days since prior embolization or radiofrequency ablation to the target lesion* NOTE: *Lesion must have demonstrated disease progression after completion of therapy
排除标准
- 未提供
结局指标
主要结局
Response rate (confirmed complete response and partial response)
次要结局
- Progression-free survival at 1 and 2 years
- Overall survival at 1 and 2 years
- Toxicity
研究者
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