NCT00165191已完成2 期
A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus
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 determine the activity of doxorubicin, cisplatin and continuous infusion of 5-fluorouracil in patients with measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction, or esophagus.
研究概览
简要总结
The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.
详细描述
- Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. In addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil intravenously as a continuous infusion for the duration of the study. In order to do this, patients will receive an infusion pump that can be carried with them. Treatment cycles will be repeated every 21 days for a maximum of 8 cycles.
- Prior to enrollment in this study and while the patient is receiving the therapy, routine blood tests and x-ryas (including chest x-rays and CT scans) will be performed to check the body's response to the treatment. Blood tests will be checked once a week and chest x-rays and CT scans will be checked every 6 weeks.
- Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 8 cycles.
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
- •Measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction or esophagus
- •No more than one prior chemotherapy regimen
- •ECOG performance status of < or equal to 2
- •Life expectancy > 12 weeks
- •ANC > 1,500/mm3
- •Hemoglobin > 9.0 gm/dl
- •Platelets > 100,000/mm3
- •SGOT < 3 x ULN
- •Total bilirubin < 2.0 mg/dl
- •Creatinine < 1.5 mg/dl
排除标准
- •Prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of study entry
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •Myocardial infarction in the past 6 months
- •Major surgery in the past 2 weeks
- •Uncontrolled serious medical or psychiatric illness
- •Pregnant or lactating women
- •Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •History or clinical evidence of congestive heart failure
结局指标
主要结局
To determine the activity of doxorubicin, cisplatin and continuous infusion of 5-fluorouracil in patients with measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction, or esophagus.
次要结局
- Assess the safety of doxorubicin, cisplatin and 5-fluorouracil when given in combination to treat this patient population
- evaluate the survival of this patient population.
研究者
研究点 (4)
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