NCT00040989撤回2 期
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 26
研究概览
简要总结
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722.
- Determine the duration of response, time to progression, and survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
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 renal cell carcinoma (RCC)
- •Recurrent AND unresectable disease OR
- •Unresectable disease OR
- •Metastatic disease
- •At least 1 bidimensionally measurable lesion by CT scan or MRI
- •No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)
- •No chronic hepatitis B or C
- •Creatinine no greater than 1.5 mg/dL
- •Calcium normal
- •Cardiovascular:
- •No clinically evident congestive heart failure
- •No serious cardiac arrhythmias
- •No symptoms of coronary heart disease
- •No symptoms of ischemia
- •HIV negative
- •No active infections requiring systemic antibacterial, antifungal, or antiviral therapy
- •No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1)
- •No substance abuse
- •No medical, psychological, or social conditions that would preclude study
- •No known or suspected allergy to study drug or any other study agents
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior anticancer vaccine therapy
- •No prior bone marrow transplantation or stem cell rescue
- •More than 4 weeks since prior thalidomide and bevacizumab
- •At least 4 weeks since prior interleukin-2 and interferon
- •No more than 2 prior regimens
- •No concurrent bone marrow transplantation or stem cell rescue
- •Chemotherapy:
- •No prior cytotoxic chemotherapy
- •No concurrent cytotoxic chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •No prior hormonal therapy for RCC
- •No concurrent hormonal therapy for RCC
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (26)
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