A Phase I Study of Gemcitabine Plus Oxaliplatin in Combination With Imatinib Mesylate (Glivec) in Patients With Gemcitabine-refractory Advanced Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The primary outcome measure for the study is to establish the Maximum Tolerated Dose of the drug regimen based on the endpoint of dose-limiting toxicity
研究概览
简要总结
The main research objective is to work out the optimal doses of the novel combination of gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine.
详细描述
Using the phase I study design, the dose of gemcitabine will be escalated in several steps to identify the highest tolerable dose that can be given safely. Based on pre-defined dose-limiting toxicity, the maximum tolerated dose of the combination will be identified and a safer dose for further evaluation of this regimen in pancreatic cancer selected. The primary objectives are therefore based around safety of the drug combination.
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
- •age > 18 years
- •gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment)
- •locally advanced or metastatic disease with measurable or non-measurable disease
- •life expectancy of greater than 10 weeks
- •prior treatment with investigational therapies including EGFR and VEGF antagonists is allowed when administered>4 weeks prior to start of therapy
排除标准
- •any serious uncontrolled medical condition
- •prior radiation treatment is not allowed
- •no prior chemotherapy within the previous 4 weeks
- •known peripheral neuropathy > CTCAE v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible
- •known brain metastases
- •lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication
- •fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception
- •pregnancy or breast feeding
研究组 & 干预措施
Treatment
Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
干预措施: Gemcitabine (Drug)
Treatment
Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
干预措施: Oxaliplatin (Drug)
Treatment
Gemcitabine plus Oxaliplatin in combination with imatinib mesylate
干预措施: Imatinib (Drug)
结局指标
主要结局
The primary outcome measure for the study is to establish the Maximum Tolerated Dose of the drug regimen based on the endpoint of dose-limiting toxicity
时间窗: 1 year
次要结局
- Progression free survival
- Overall survival
- Response rate for those with measurable disease
- Characterise safety profile of Gemcitabine Plus Oxaliplatin in Combination with imatinib mesylate (Glivec) in Patients with Gemcitabine-Refractory Advanced Adenocarcinoma of the Pancreas