NCT00141531已完成2 期
Phase II Study of Intravesical Instillation of EOQUIN™ in High Risk Superficial Bladder Cancer
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
- 53
- 试验地点
- 1
- 主要终点
- Time to progression / Duration of remission following transurethral resection of superficial bladder cancer
研究概览
简要总结
A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial bladder tumors, and the response and duration of response in patients with carcinoma in situ of the bladder.
详细描述
Endpoints: Time to recurrence, duration of response and safety
Number of Patients: 53 patients
Study Design: Non-randomized, open-label study.
Key Inclusion Criteria: High-risk patients according to EAU criteria defined as
- pT1 and/or Grade 2b-3, or multiple and highly recurrent
- histologically confirmed carcinoma in situ (CIS)
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
- •Patients with high risk superficial bladder cancer according to EAU criteria defined as:
- •pT1 and/or Grade 2b-3, or multiple and highly recurrent
- •histologically confirmed carcinoma in situ
- •All visible lesions must be completely removed by transurethral resection (TUR) at entry to the study
- •Normal bimanual examination under anesthesia (no palpable masses)
- •Absence of upper urinary tract tumor confirmed by intravenous pyelography (IVP) or CT scan or retrograde urogram within 6 months from the beginning of treatment
- •Patient with ZUBROD-ECOG-WHO performance status of 0-2 (see Appendix 2)
- •Over 18 years of age
- •Patients must be fully informed of the investigational nature of the study and signed written informed consent must be obtained prior to any study specific investigations.
排除标准
- •Patients having muscle-invasive disease (T2 or greater)
- •Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months
- •Patients with existing urinary tract infection or recurrent severe bacterial cystitis
- •Patients with urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra
- •Patients with history of other primary malignancy (other than squamous or basal cell skin cancers or cone biopsied Cis of the uterine cervix or prostate carcinoma treated curatively with normal PSA values at inclusion) in the last five years
- •Patients with active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose to the development of complications from the administration of intravesical therapy and or general anesthesia
- •Patients who, in the opinion of the investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders)
- •Women who are pregnant or lactating. Individuals of reproductive potential may not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partner
研究组 & 干预措施
Apaziquone
Active Comparator
干预措施: Apaziquone (Drug)
结局指标
主要结局
Time to progression / Duration of remission following transurethral resection of superficial bladder cancer
时间窗: 18 months
次要结局
- Additional safety data(18 months)
- Rate of upstaging on recurrence(18 months)
研究者
研究点 (1)
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