Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Overall response rate
研究概览
简要总结
This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.
详细描述
High dose MVAC and Cisplatin/Gemcitabine combination regimens have shown comparable efficacy in the first line treatment of advanced or metastatic bladder cancer, whereas the latter regimen has better tolerability. The efficacy and tolerability of the sequential administration of these two regimens is not known.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder.
- •Metastatic or locally advanced disease.
- •No prior chemotherapy.
- •Performance status (World Health Organization) 0-
- •Measurable or evaluable disease.
- •Measurable disease is defined as at least 1 unidimensional measurable lesion
- •≥20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
- •Adequate liver (bilirubin ≤ 1.5 Upper Normal Limit, serum glutamate-pyruvate aminotransferase/serum glutamic pyruvic transaminase ≤ 2 Upper Normal Limit, ALP ≤ 2.5 Upper Normal Limit), renal (creatinine ≤ 1.5 Upper Normal Limit) and bone marrow (absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3) function.
- •Life expectancy > 3 months.
- •Patients must be able to understand the nature of this study and give written informed consent.
排除标准
- •History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias).
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
- •Active infection.
- •Uncontrolled inflammation.
- •Pregnant or lactating women.
- •Psychiatric illness or social situation that would preclude study compliance.
研究组 & 干预措施
1
MVAC -> GEM+CDDP
干预措施: Methotrexate (Drug)
1
MVAC -> GEM+CDDP
干预措施: Vinblastine (Drug)
1
MVAC -> GEM+CDDP
干预措施: Doxorubicin (Drug)
1
MVAC -> GEM+CDDP
干预措施: Cisplatin (Drug)
1
MVAC -> GEM+CDDP
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
次要结局
- Time to tumor progression(1-year)
- Overall survival(1-year)
- Toxicity profile(Toxicity assessment on each chemotherapy cycle)