NCT00052754已完成2 期
Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1
European Organisation for Research and Treatment of Cancer - EORTC32 个研究点 分布在 4 个国家目标入组 48 人开始时间: 2002年10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
- 48
- 试验地点
- 32
- 主要终点
- Progression-free rate at 12 weeks
研究概览
简要总结
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.
详细描述
OBJECTIVES:
- Determine the therapeutic activity of gefitinib, in terms of progression-free rate, in patients with locally advanced or metastatic synovial sarcoma expressing HER1.
- Determine the toxicity of this drug in these patients.
- Determine the objective response, in terms of time to onset and duration of response, in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive oral gefitinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven advanced or metastatic synovial sarcoma that is not amenable to surgery, radiotherapy, or combined modality treatment with curative intent
- •HER1 antigen expression
- •Must have received at least 1 prior chemotherapy regimen comprising doxorubicin and/or ifosfamide
- •At least 1 measurable lesion with evidence of progression within 3 months of study
- •Osseous lesions and pleural effusions are not considered measurable
- •No symptomatic or known CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC greater than 3,000/mm^3
- •Granulocyte count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Albumin at least 25 g/L
- •Creatinine no greater than 2 times ULN OR
- •Creatinine clearance greater than 65 mL/min
- •Cardiovascular
- •No history of severe cardiovascular disease
- •No evidence of clinically active interstitial lung disease
- •Asymptomatic chronic stable radiographic changes allowed
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No known severe hypersensitivity to gefitinib or any of its excipients
- •No other primary malignant tumor except adequately treated carcinoma in situ of the cervix, basal cell skin cancer, or any other malignant tumor in complete remission for at least 3 years
- •No other severe medical illness
- •No psychosis
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •At least 28 days since prior chemotherapy and recovered
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 3 months since prior radiotherapy to measurable lesion and recovered
- •No concurrent radiotherapy for soft tissue sarcoma
- •Concurrent palliative radiotherapy to nontarget lesions allowed
- •Not specified
- •More than 28 days since prior unapproved or investigational drugs and recovered
- •No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's Wort)
- •No other concurrent cytostatic agents
- •No other concurrent tyrosine kinase activity inhibitors
- •No other concurrent systemic therapy for soft tissue sarcoma
排除标准
- 未提供
结局指标
主要结局
Progression-free rate at 12 weeks
次要结局
- Toxicity as assessed by CTC 2.0
- Response as assessed by RECIST criteria
- Time to onset of response
- Duration of response
- Overall survival
研究者
研究点 (32)
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