NCT00039169Unknown2 期
An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer
Theradex26 个研究点 分布在 2 个国家开始时间: 2001年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 26
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer.
详细描述
OBJECTIVES:
- Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with advanced renal cell cancer treated with BAY 59-8862.
- Determine the overall survival in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Determine the duration of response (CR and PR) in patients treated with this drug.
- Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
- Determine the pharmacokinetic profile of this drug in selected patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years.
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 or cytologically confirmed advanced renal cell cancer
- •Unresectable, refractory, and/or metastatic
- •At least 1 measurable lesion
- •A CNS lesion cannot be the sole target lesion
- •Lesions within a previously irradiated field are not considered measurable
- •No metastatic brain or meningeal tumors unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry
- •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 9.0 g/dL
- •Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)
- •PT, INR, and PTT less than 1.5 times ULN
- •No chronic hepatitis B or C
- •Creatinine no greater than 2 times ULN
- •Cardiovascular:
- •No clinically evident congestive heart failure
- •No serious cardiac arrhythmias
- •No prior coronary artery disease or ischemia
- •No prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication
- •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 or medical, psychological, or social conditions that would preclude study compliance
- •No active clinically serious infections
- •No other condition that is unstable or would preclude study participation
- •No grade 2 or greater pre-existing peripheral neuropathy
- •No history of seizure disorder
- •Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 months since prior bone marrow or peripheral blood stem cell transplantation
- •No more than 2 prior immunotherapy regimens (interleukin-2 or interferon only)
- •At least 4 weeks since prior immunotherapy
- •At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF])
- •More than 4 weeks since prior thalidomide or bevacizumab
- •No prior anticancer vaccines
- •No concurrent prophylactic G-CSF
- •Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed
- •Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months before study
- •Chemotherapy:
- •No prior systemic cytotoxic chemotherapy
- 另有 24 项未显示
排除标准
- 未提供
研究者
研究点 (26)
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