NCT00017329已完成2 期
Phase II Trial of PS341 (NSC 681239) in Patients With Advanced 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
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed renal cell carcinoma
- •Metastatic disease
- •Unidimensionally measurable disease
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 3 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 no greater than 1.5 mg/dL
- •ALT/AST no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •No pre-existing neuropathy of grade 1 or greater
- •No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy and recovered
- •No concurrent biologic therapy
- •Chemotherapy:
- •No prior cytotoxic therapy
- •No concurrent cytotoxic therapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •At least 4 weeks since prior major surgery
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究者
研究点 (1)
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