A Phase I Dose Escalation of ZD1839 (Iressa®) (Days 1 and 2) and Docetaxel (Day 3) Every 3 Weeks in Patients With an Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gefitinib with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib when given with docetaxel in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of gefitinib when administered with docetaxel in patients with advanced solid tumors.
- Determine the safety and efficacy of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of gefitinib.
Patients receive oral gefitinib once daily on days 1 and 2 and docetaxel IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 advanced solid tumor
- •Failed standard treatment OR no standard treatment exists
- •Measurable or evaluable indicator lesions
- •No uncontrolled CNS metastases (i.e., any known CNS lesion that is progressive [e.g., ≥ 25% growth], symptomatic, and/or requires escalating doses of corticosteroids)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2.0 times ULN
- •Creatinine ≤ 1.5 mg/dL OR
- •Creatinine clearance ≥ 55 mL/min
- •Cardiovascular
- •No congestive heart failure
- •No recent myocardial infarction
- •No unstable angina
- •No uncontrolled hypertension
- •No clinically active interstitial lung disease
- •Chronic, stable, asymptomatic radiographic changes allowed
- •No corneal abnormality
- •No history of dry eye syndrome or ocular surface diseases
- •No known severe hypersensitivity to gefitinib or any of its excipients
- •No unstable systemic disease
- •No active infection
- •No other significant medical history or unstable medical condition
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No sperm donation during and for 3 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy
- •No more than 2 prior chemotherapy regimens for metastatic cancer
- •No prior docetaxel
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy to a major bone marrow-containing area
- •Not specified
- •No prior gefitinib or erlotinib
- •No other prior epidermal growth factor receptor tyrosine kinase inhibitors
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排除标准
- 未提供