NCT00276861终止2 期
Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Response Rate as Measured by RECIST Criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.
详细描述
OBJECTIVES:
Primary
- Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
- Determine the duration of response (complete or partial) in patients treated with this regimen.
- Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving this regimen.
- Evaluate the toxicity associated with the administration of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Response Rate as Measured by RECIST Criteria
时间窗: 4 - 6 months
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
次要结局
- Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment(6 months)
研究者
研究点 (2)
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