NCT00014183已完成2 期
A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.
详细描述
OBJECTIVES:
- Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839.
- Determine the median time to objective progression in these patients receiving this drug.
- Determine the toxic effects of this drug in this patient population.
- Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery
- •Evidence of disease progression
- •Measurable disease
- •At least 20 mm with conventional techniques OR
- •At least 10 mm with spiral CT scan
- •No brain metastases
- •Malignant tissue available
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No prior allergy to compounds of similar chemical or biologic composition to ZD 1839
- •No ongoing or active infection
- •No other uncontrolled illness or psychiatric condition that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens
- •At least 4 weeks since prior immunotherapy and recovered
- •No concurrent immunotherapy
- •Chemotherapy:
- •No more than 1 prior chemotherapy regimen
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No prior therapy for metastatic disease
- •No other concurrent investigational agents
- •No concurrent oral retinoids
排除标准
- 未提供
研究者
研究点 (2)
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