NCT00085475已完成2 期
Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)
European Organisation for Research and Treatment of Cancer - EORTC14 个研究点 分布在 4 个国家目标入组 17 人开始时间: 2004年4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
- 17
- 试验地点
- 14
- 主要终点
- Progression-free rate at 14 weeks
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
- Determine the progression-free rate at 14 weeks in patients treated with this drug.
Secondary
- Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
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 confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma
- •Locally advanced or metastatic disease
- •Measurable disease
- •Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
- •Documented progressive disease within the past 3 months
- •Previously irradiated lesions must show disease progression
- •Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization
- •Translocation t(17;22)(q22;q13)
- •No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 mg/dL* NOTE: *Transfusion allowed
- •SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
- •Bilirubin ≤ 1.5 times ULN
- •No uncontrolled hepatic disease
- •Creatinine ≤ 1.5 times ULN
- •No uncontrolled renal disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •HIV negative
- •No uncontrolled diabetes
- •No active or uncontrolled infection
- •No concurrent severe or uncontrolled medical disease
- •No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent
- •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 currently in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 28 days since prior biologic therapy
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- •No concurrent anticancer biologic agents
- •Chemotherapy
- •See Disease Characteristics
- •More than 28 days since prior chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 6 months since prior radiotherapy
- •No concurrent radiotherapy
- •Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion
- •Not specified
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free rate at 14 weeks
次要结局
- Response rate as assessed by RECIST criteria
- Progression-free survival
- Overall survival
- Duration of response
- Toxicity as assessed by CTC 3.0
研究者
研究点 (14)
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