NCT00047216已完成2 期
A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 7
- 主要终点
- 1-year recurrence-free survival
研究概览
简要总结
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.
详细描述
OBJECTIVES:
- Determine the 1-year recurrence-free survival rate of patients with stage 0 or I recurrent transitional cell carcinoma of the bladder treated with tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed transitional cell carcinoma (TCC) of the bladder with or without associated carcinoma in situ
- •Stage 0 or I (Ta or T1)
- •Grade 1, 2, or 3 TCC
- •Cystoscopically and histologically confirmed recurrent disease after at least 1 course of standard first-line intravesical therapy (e.g., BCG or mitomycin) within the past 12 months
- •Complete transurethral resection of bladder tumor performed within past 4 weeks
- •Rendered clinically and cystoscopically tumor free
- •Negative cytology
- •No upper tract TCC by intravenous pyelogram, retrograde pyelogram, or CT scan of kidneys (with contrast)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 1 year
- •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 normal
- •AST/ALT no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.25 times ULN OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •Able to swallow and retain oral medication
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reactions to compounds of similar chemical or biological composition to study drug (e.g., other imidazoles such as ketoconazole and other imidazole-based antifungal agents, losartan, metronidazole, or cimetidine)
- •No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer
- •No other uncontrolled concurrent illness that would preclude study participation
- •No ongoing or active infection
- •No active peptic ulcer disease
- •No psychiatric illness or social situation that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior systemic chemotherapy for bladder cancer
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for bladder cancer
- •See Disease Characteristics
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
1-year recurrence-free survival
次要结局
- Molecular changes in the host tissue
- Progression rate at 3, 6, 9, and 12 months
- Recurrence rate at 3, 6, 9, and 12 months
- Time to treatment failure
- Survival rate
研究者
研究点 (7)
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