NCT00084513已完成1 期
Phase I of Trastuzumab and Imatinib Mesylate (Gleevec®, Formerly Known as STI-571) in Patients With Recurrent or Metastatic Her-2/Neu Expressing Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Response as measured by RECIST criteria every 9 weeks
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Giving trastuzumab together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with trastuzumab in treating patients with recurrent or metastatic HER2/neu-expressing (producing) cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of imatinib mesylate when administered with trastuzumab (Herceptin®) in patients with recurrent or metastatic HER2/neu-overexpressing cancer.
- Determine response in patients treated with this regimen.
Secondary
- Correlate the number of circulating tumor cells with radiographic imaging in patients treated with this regimen.
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 or cytologically confirmed cancer that overexpresses HER2/neu, measured 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
- •Recurrent or metastatic disease
- •Meets 1 of the following criteria for measurable or evaluable disease:
- •Unidimensionally measurable disease at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Evaluable disease, defined as a lesion on physical examination or imaging study that can be assessed as to changes in size but cannot be clearly measured in 1 dimension (e.g., pleural effusions, ascites, or bone disease)
- •No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
- •Prior controlled brain parenchymal disease allowed provided at least 8 weeks since prior therapy AND no symptomatic progression off corticosteroids
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •ALT and AST ≤ 2.0 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.0 times ULN
- •Bilirubin ≤ 1.3 mg/dL
- •No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •Ejection fraction ≥ lower limit of normal by MUGA
- •No uncontrolled or significant cardiovascular disease
- •No myocardial infarction within the past 6 months
- •No ischemic heart disease requiring medication
- •No congestive heart failure
- •No uncontrolled or significant pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after study participation
- •No active unresolved infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior trastuzumab (Herceptin®) allowed
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts
- •No other concurrent anticancer biologic agents
- •Chemotherapy
- •Prior chemotherapy for metastatic disease allowed
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No concurrent anticancer chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy and recovered
- •More than 2 weeks since prior major surgery
- •At least 7 days since prior antibiotics
- •No concurrent parenteral antibiotics
- •No other concurrent anticancer agents
- •No other concurrent investigational drugs
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Response as measured by RECIST criteria every 9 weeks
Maximum tolerated dose (MTD) of imatinib mesylate given concurrently with trastuzumab (Herceptin®) as measured by CTC v 3.0 at course 1
次要结局
- Circulating tumor cells in blood as measured by Immunicom Cell PrepTM at baseline, every 3 weeks until week 9, and then with each disease re-evaluation
- Phosphorylation status of AKT, extracellular signal-regulated kinase (ERK), and KIT as measured by western blot and/or immunohistochemistry at baseline and week 9
研究者
研究点 (1)
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