NCT00253565已完成1 期
A Phase I Dose Escalation Study of Imatinib Mesylate (Gleevec/STI571) Plus Capecitabine (Xeloda) in Advanced Solid Tumor Malignancies
Herbert Hurwitz2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2003年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
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 and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with capecitabine 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 capecitabine in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors.
Secondary
- Determine the non-dose-limiting toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
- Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
- Determine, preliminarily, the effect of this regimen on wound angiogenesis in these patients.
- Correlate pharmacokinetic parameters with clinical toxicity, clinical activity, or surrogate biomarker activity of this regimen in these patients.
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 malignant solid tumors for which no standard effective therapy exists OR such therapy is refused
- •Previously treated brain metastases that are currently asymptomatic allowed
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 2,000/mm^3
- •Platelet count > 100,000 mm^3
- •Hemoglobin > 9.0 g/dL
- •Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
- •SGOT and SGPT < 2.5 times ULN
- •Bilirubin < 1.5 times ULN
- •Creatinine clearance > 50 mL/min
- •Cardiovascular
- •No congestive heart failure
- •No symptomatic coronary artery disease
- •No uncontrolled cardiac arrhythmias
- •No myocardial infarction within the past 12 months
- •No other clinically significant cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No prior unanticipated severe reaction to fluoropyrimidine therapy
- •No known sensitivity to fluorouracil
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 28 days since prior biologic therapy
- •Chemotherapy
- •More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C)
- •Endocrine therapy
- •At least 90 days since prior steroids for the treatment of brain metastases
- •More than 28 days since prior hormonal therapy
- •Radiotherapy
- •At least 90 days since prior radiotherapy for the treatment of brain metastases
- •More than 28 days since other prior radiotherapy
- •No prior pelvic radiotherapy > 30% of the bone marrow
- •More than 28 days since prior surgery and recovered
排除标准
- 未提供
研究者
Herbert Hurwitz
Associate Professor
Duke University
研究点 (2)
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