NCT00112632已完成2 期
Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha
Technical University of Munich18 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2005年2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
- 发起方
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- Overall tumor response (complete response, partial response, stable disease, and progression of disease)
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.
详细描述
OBJECTIVES:
Primary
- Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate.
- Determine histological response in patients treated with this drug.
Secondary
- Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug.
- Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
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 gastrointestinal stromal tumor
- •Locally advanced disease
- •Potentially resectable disease*
- •No tumor that can be completely resected (R0) with sufficient margins NOTE: *Multivisceral resection may be necessary
- •Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry
- •At least 1 site of measurable disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count > 100,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
- •Bilirubin < 1.5 times ULN
- •No chronic active hepatitis
- •No cirrhosis
- •No other chronic liver disease
- •Creatinine < 1.5 times ULN
- •No chronic renal disease
- •Cardiovascular
- •No New York Heart Association class III-IV cardiac disease
- •No congestive heart failure
- •No myocardial infarction within the past 6 months
- •No active uncontrolled infection
- •No known HIV positivity
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- •Must be medically fit to undergo surgery
- •No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
- •No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
- •No uncontrolled diabetes
- •No other severe or uncontrolled medical disease
- •No significant history of noncompliance to medical regimens
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer biologic agents
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
- •No concurrent anticancer chemotherapy
- •Endocrine therapy
- •No concurrent systemic corticosteroid therapy unless approved by the study sponsor
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •No prior radiotherapy to ≥ 25% of bone marrow
- •More than 2 weeks since prior major surgery except tumor biopsy
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall tumor response (complete response, partial response, stable disease, and progression of disease)
次要结局
- Time to progression of disease
- Overall survival
研究者
研究点 (18)
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