NCT00182702已完成2 期
A Phase II Trial of BMS 247550 (Ixabepilone) in Advanced Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Objective response rate (partial or complete)
研究概览
简要总结
This phase II trial is studying how well ixabepilone works in treating patients with metastatic, recurrent, or unresectable kidney cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with metastatic, recurrent, or unresectable renal cell carcinoma treated with ixabepilone.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival rates in patients treated with this drug.
II. Determine the toxicity of this drug in these patients. III. Correlate VHL gene mutations with response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed renal cell carcinoma of 1 of the following subtypes:
- •Clear cell
- •Papillary, type I or II
- •Chromophobe
- •Collecting duct
- •Medullary
- •Metastatic, recurrent, or unresectable disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No known active brain metastases requiring steroid or anticonvulsant therapy
- •Patients with definitively treated brain metastases are eligible provided they are not on steroids or anticonvulsants AND show no evidence of disease progression for ≥ 3 months after completion of definitive therapy
- •Performance status - ECOG 0-2
- •At least 3 months
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Glomerular filtration rate ≥ 50 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No ongoing or active infection
- •No HIV positivity
- •No peripheral neuropathy > grade 1
- •No psychiatric illness or social situation that would preclude study compliance
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
- •No history of severe hypersensitivity reaction to agents containing Cremophor® EL
- •No other active malignancy
- •Curatively treated malignancies are allowed provided the risk of recurrent disease at the time of study enrollment is < 20%
- •No other uncontrolled illness
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No prior tubule inhibitors, including, but not limited to, any of the following:
- •Vinca alkaloids (e.g., vinblastine, vincristine, or vinorelbine)
- •Taxanes (e.g., docetaxel or paclitaxel)
- •Epothilones
- •No other concurrent chemotherapy
- •See Disease Characteristics
- •No concurrent hormonal therapy except steroids for adrenal failure or hypersensitivity prophylaxis or hormones for non-disease related conditions (e.g., insulin for diabetes)
- •More than 4 weeks since prior radiotherapy and recovered
- •No concurrent palliative radiotherapy
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment
Experimental
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: ixabepilone (Drug)
Treatment
Experimental
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective response rate (partial or complete)
时间窗: Up to 5 years
次要结局
- Progression-free survival (PFS)(From the start of treatment to time of progression, assessed up to 5 years)
- Overall survival (OS)(Up to 5 years)
研究者
研究点 (1)
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