NCT00093405已完成2 期
A Phase II Study Of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG)In Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Efficacy (complete and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. 17-N-allylamino-17-demethoxygeldanamycin may also stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic papillary or clear cell renal cell carcinoma.
Secondary
- Determine the safety of this drug in these patients.
- Correlate tumor c-met expression with response in patients treated with this drug.
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 renal cell carcinoma
- •Papillary OR clear cell histology
- •If other histologies are present, clear cell or papillary must be predominant
- •Metastatic disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No brain metastases unless previously treated with radiotherapy or surgery AND asymptomatic with no active brain metastases detectable by CT scan or MRI for ≥ 6 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 2.0 times ULN
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No severe valvular disease
- •No severe debilitating pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No allergy to egg or egg products
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
- •No active or ongoing infection requiring IV antibiotics
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No more than 1 prior cytokine-based regimen
- •No concurrent biologic therapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •More than 4 weeks since prior major surgery
- •Recovered from prior therapy
- •No more than 1 prior non-cytokine-based regimen
- •No other prior systemic treatment regimens
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Efficacy (complete and partial response)
次要结局
- Toxicity
研究者
研究点 (1)
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