A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Objective response
研究概览
简要总结
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.
详细描述
PRIMARY OBJECTIVES:
I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer.
OUTLINE:
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.
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
- •Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
- •Patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
- •>= 4 weeks since prior RT or chemotherapy
- •Patients must have measurable disease
- •CTC (ECOG) Performance Status =< 1
- •No evidence of NYHA functional class III or IV heart disease
- •Baseline EKG with QTc < 500 ms
- •Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
- •Granulocytes > 1500/ml
- •Platelet count > 100,000/ml
- •Bilirubin =< Upper limits of normal (ULN)
- •Serum Creatinine < 2.0 x ULN
排除标准
- 未提供
研究组 & 干预措施
Treatment (arsenic trioxide)
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.
干预措施: arsenic trioxide (Drug)
结局指标
主要结局
Objective response
时间窗: Up to 2 years
95% confidence intervals will be computed using binomial distribution.
Toxicity graded using the CTC
时间窗: Up to 2 years
Reported by type, frequency and severity.
次要结局
- Time to disease progression(From the initiation of treatment to the date of progressive disease, assessed up to 2 years)
- Duration of objective response(Up to 2 years)