Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
概览
- 阶段
- 1 期
- 干预措施
- gemcitabine hydrochloride
- 疾病 / 适应症
- Pancreatic Cancer
- 发起方
- Centre Antoine Lacassagne
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical or laboratory toxicities as assessed by CTC
- 状态
- 已完成
- 最后更新
- 9天前
概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.
详细描述
OBJECTIVES: Primary * Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer. Secondary * Analyze the limiting toxicities according to CTC. * Analyze the toxicity according to CTC. * Determine the recommended dose. * Determine the pharmacokinetic dosages of the three drugs. * Analyze interactions between the drugs. OUTLINE: This is a multicenter study. Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.
研究者
入排标准
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Advanced disease
- •No standard curative therapy available
- •Must have received prior first-line chemotherapy
- •No brain metastasis
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 8 weeks
- •ANC ≥ 1.5 x 10\^9/ L
排除标准
- 未提供
研究组 & 干预措施
gemcitabine, capecitabine, erlotinib
干预措施: gemcitabine hydrochloride
gemcitabine, capecitabine, erlotinib
干预措施: erlotinib hydrochloride
gemcitabine, capecitabine, erlotinib
干预措施: capecitabine
结局指标
主要结局
Clinical or laboratory toxicities as assessed by CTC
时间窗: 1 year