NCT00962312已完成2 期
A Phase II Study of Lapatinib and Capecitabine in the Treatment of Metastatic Pancreatic Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 9
- 主要终点
- 6-month survival rate
研究概览
简要总结
RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of lapatinib ditosylate and capecitabine as first-line therapy, in terms of overall survival, in patients with metastatic pancreatic cancer.
Secondary
- To evaluate the progression-free survival of patients treated with this regimen.
- To evaluate the overall response rate (complete and partial responses) in patients treated with this regimen.
- To evaluate the clinical benefit (complete response, partial response, or stable disease for ≥ 6 months) of this regimen in these patients.
- To evaluate the qualitative and quantitative toxicity associated with this regimen in these patients.
- To determine the intra-tumoral expression of ErbB1 (EGFR) and ErbB2 (HER2/neu) in these patients.
- To seek pilot information on the intra-tumoral expression of markers of tumor resistance and sensitivity to treatment, including resistance drug pump expression and growth factor receptor expression.
- To collect pre- and post-treatment serum samples from these patients for proteomic analyses to elucidate if any serum cancer marker profiles can be detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Capecitabine and Lapatinib
Experimental
干预措施: lapatinib ditosylate (Drug)
Capecitabine and Lapatinib
Experimental
干预措施: capecitabine (Drug)
结局指标
主要结局
6-month survival rate
时间窗: 6 months
次要结局
- Progression-free survival(6 months)
- Overall response rate(up to 6 months)
- Clinical benefit(6 months)
- Safety and tolerability(Throughout course of study)
- Tumour biomarker analysis(Currently ongoing)
研究者
研究点 (9)
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