NCT00101842已完成1 期
Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Toxicity will be measured by standard grading methods.
研究概览
简要总结
The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.
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
- 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
- •Biopsy-proven metastatic bladder cancer
- •No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment
- •Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment
- •18 years of age and older
排除标准
- •Pure adeno- or squamous urothelial cancer
- •Brain metastases that causes symptoms
- •Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
- •Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol
- •Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled
结局指标
主要结局
Toxicity will be measured by standard grading methods.
次要结局
- Time to progressive disease is defined as time from enrollment to first date of disease progression.
- Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.
- Survival time is defined as time from enrollment to death from any cause.
- Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).
- Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.
研究者
研究点 (1)
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