NCT00424723已完成2 期
A Phase II Study of Pemetrexed in Patients With Advanced Neuroendocrine Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) pemetrexed has on patients with advanced neuroendocrine tumors.
详细描述
- 1 cycle is equal to 21 days. Every 21 days the following will be performed: a review of the patients symptoms and medications; physical exam; blood tests; vital signs; and pemetrexed infusion.
- Every 3 cycles (9 weeks) an assessment of disease extent by CT scan and a 24 hour urine collection (if applicable) will be performed.
- Before patients start receiving pemetrexed, they will be given folic acid, vitamin B12 and dexamethasone to help reduce the chance of significant side effects. Dexamethasone will be taken the evening before, the morning before and the evening after receiving pemetrexed. Folic acid should be taken daily beginning 5-7 days before the first dose of pemetrexed and should be continued for three weeks after the last dose of pemetrexed. Vitamin B12 will be given as an injection 1-2 weeks before the first dose of pemetrexed and once every 9 weeks until 3 weeks after the last dose of pemetrexed.
- Patients can continue to receive treatment with pemetrexed unless there is evidence that their tumor has grown or they are experiencing serious side effects.
- Immediately after the patient has completed the study, they will be given a physical exam, including vital signs, a CT scan, and blood tets. The study staff will continue to monitor the patients health either by clinic visits or phone calls every three months for the remainder of your life.
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
- •Metastatic or locally unresectable neuroendocrine tumor, excluding small cell carcinoma
- •Measurable tumor
- •18 year of age or older
- •ECOG performance status of 0,1 or 2
- •Life expectancy of greater than 12 weeks
- •WBC: > 3.0/mm3
- •Plts: > 100,000/mm3
- •Bilirubin: < 2.0 mg/dl
- •AST < 3 x ULN (except in patients with known hepatic metastases wherein SST may be < 5 x ULN)
- •Neutrophils > 1000/mm3
- •Creatinine Clearance > 45 ml/min. Should be measured using the standard Cockroft-Gault formula
排除标准
- •Prior treatment with pemetrexed
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •Myocardial infarction in the past 6 months
- •Major surgery in the past two weeks
- •Uncontrolled serious medical or psychiatric illness
- •Pregnant or lactating women
结局指标
主要结局
To assess the radiologic response rate associated with pemetrexed in patients with neuroendocrine tumors.
时间窗: 2 years
次要结局
- To perform an analysis of the biochemical response rate(2 years)
- to assess the toxicity associated with pemetrexed(2 years)
- and to assess the progression-free and overall survival of patients.
研究者
研究点 (2)
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