NCT00885066已完成1 期
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical or laboratory toxicities as assessed by CTC
研究概览
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.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Platelet count ≥ 130 x 10^9/ L
- •Hemoglobin ≥ 10 g/dL
- •Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No intolerance or hypersensitivity to any of the drugs being tested
- •No history of interstitial lung disease
- •No history of severe cardiac disease
- •No serious uncontrolled infection
- •No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
- •Must not be deprived of liberty or under guardianship
- •Must not be on probation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior erlotinib hydrochloride
- •No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
- •More than 14 days since participation in another clinical trial
排除标准
- 未提供
研究组 & 干预措施
gemcitabine, capecitabine, erlotinib
Experimental
干预措施: gemcitabine hydrochloride (Drug)
gemcitabine, capecitabine, erlotinib
Experimental
干预措施: erlotinib hydrochloride (Drug)
gemcitabine, capecitabine, erlotinib
Experimental
干预措施: capecitabine (Drug)
结局指标
主要结局
Clinical or laboratory toxicities as assessed by CTC
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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