NCT00021099已完成2 期
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
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
- 45
- 试验地点
- 1
- 主要终点
- The proportion of patients with clinical response measured using RECIST criteria
研究概览
简要总结
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
详细描述
OBJECTIVES:
I. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.
II. Assess the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no).
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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 confirmed transitional cell carcinoma (TCC) of the urothelium(renal pelvis, ureter, bladder, or urethra)
- •Mixed histology carcinoma with a TCC component allowed
- •Progressive regional disease
- •Metastatic disease
- •Failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting
- •May have included taxane-based therapy
- •Measurable disease outside prior irradiation field
- •Previously resected and irradiated CNS metastases with evidence of stable disease allowed
- •Performance status - ECOG 0-2
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •No prior severe cardiovascular disease (American Heart Association class III or IV heart disease)
- •No uncontrolled congestive heart failure
- •No ventricular dysrhythmia
- •No active unresolved infection requiring parenteral antibiotics within the past week
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior systemic biologic response modifier therapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior major surgery and recovered
排除标准
- 未提供
研究组 & 干预措施
Treatment (ixabepilone)
Experimental
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: ixabepilone (Drug)
结局指标
主要结局
The proportion of patients with clinical response measured using RECIST criteria
时间窗: Up to 3 years
次要结局
- Toxicity graded using the NCI CTC version 2.0(Up to 30 days after completion of study treatment)
研究者
研究点 (1)
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