Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 25
- 主要终点
- To determine the antitumor efficacy ( response rate) of sunitinib
研究概览
简要总结
Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity.
Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy.
No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority.
Several drugs have been used in second line for metastatic disease with poor results.
The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine).
No previous studies have been published with sunitinib in metastatic bladder cancer.
详细描述
OBJECTIVES
- PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib
- SECONDARY To determine: safety, duration of response, Quality of life (QoL), progression free survival (PFS) and overall survival (OS).
PLAN OF TREATMENT Patients received sunitinib at a starting dose of 50 mg per day in repeated 6-week cycles for 4 consecutive weeks followed by 2 weeks off treatment.
Sunitinib was self-administered orally once daily without regard to meals. Dose reduction for toxicity was allowed to 37.5 until 25 mg/day depending on the type and severity of toxicity encountered.
Sunitinib treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cytological confirmation of UROTHELIAL carcinoma
- •Failure of Cisplatin-gemcitabine regimen as first-line
- •Presence of measurable metastases
- •Performance status 0-1 ECOG
- •Age of 18 years or older
- •Written informed consent
- •Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).
排除标准
- •administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)
- •brain metastases
- •significant cardiac events within the 6 months prior to study drug administration.
研究组 & 干预措施
SUNITINIB
干预措施: SUNITINIB (Drug)
结局指标
主要结局
To determine the antitumor efficacy ( response rate) of sunitinib
时间窗: 12 weeks
次要结局
- QOL(6 WEEKS)
- TOXICITY ACCORDING NCI VERSION 3 CRITERIA(EVERY WEEK)