NCT00215462已完成2 期
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
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
- 4
- 主要终点
- To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
研究概览
简要总结
The purpose of this study is to collect anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors. We will also collect information on the toxicities of vinorelbine in these patients.
详细描述
- Patients will receive vinorelbine intravenously once per week for eight weeks. These treatments will be repeated after the initial eight weeks as long as the patient continues to receive benefit from the treatment. If the patient experiences significant toxicities, the dose may be reduced or the chemotherapy may be discontinued.
- Before beginning treatment and during therapy, routine laboratory tests, scans and x-rays will be done to check the body's response to treatment. A physical exam will be done at the start of the study and before each course of treatment. Scans will be done after eight weeks of therapy.
- Patients will remain on this study as long as their disease does not become worse or they do not experience severe side effects.
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
- •Locally unresectable or metastatic esophageal adenocarcinoma. Locally unresectable or metastatic gastric adenocarcinoma. Only patients with measurable tumors are eligible.
- •No more than one prior chemotherapy regimen
- •ECOG performance status of 0-1
- •Life expectancy of > 12 weeks
- •Greater than or equal to 1,200 calorie/day intake
- •ANC > 1,500/mm3
- •AST < 3 x ULN
- •Total bilirubin < 2.0 ng/dl
- •Platelets > 100,000/mm3
- •Serum creatinine < 2.0 mg/dl
排除标准
- •Prior therapy with vinca alkaloids
- •Chemotherapy within the past three weeks
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •Peripheral neuropathy > 1
结局指标
主要结局
To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
次要结局
- To evaluate the toxicities of vinorelbine in this patient population.
研究者
研究点 (4)
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