Gemcitabine, Oxaliplatin and Capecitabine (GEMOXEL) for Patients With Advanced Pancreatic Adenocarcinoma (APC): A Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Response rate
研究概览
简要总结
Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.
详细描述
Primary Objectives:
- Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC
- Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC
Secondary Objectives:
- to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC
Primary Endpoints:
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
- •Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
- •Disease non-resectable and locally advanced or metastatic
- •Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
- •Age >18 years
- •Karnofsky performance status ≥ 60%
- •Life expectancy of at least 3 months
- •Written informed consent
- •Willing and able to comply with the protocol for the duration of the study
排除标准
- •Prior chemotherapy for pancreatic cancer
- •Prior adjuvant radio- or radiochemotherapy for pancreatic cancer within 12 months of inclusion
- •Known CNS metastases at the time of enrollment
- •Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl
- •Serum creatinine > 1.25 x ULN
- •ASAT, ALAT and alkaline phosphatase > 2.5 ULN or > 5 ULN in the presence of liver metastasis, Bilirubin > 1.5 ULN (after treatment of obstructive jaundice eg. stent)
- •Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)
- •Men and women of reproductive potential who are not using an effective method of contraception
- •Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months
- •Neurological disease with dys-/paraesthesias > grade 1 according to NCI CTC
- •Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)
- •Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance
研究组 & 干预措施
single
single arm study with triple combination chemotherapy
干预措施: gemcitabine, oxaliplatin, capecitabine (Drug)
结局指标
主要结局
Response rate
时间窗: 6 weeks
次要结局
- Progression-free survival and overall survival(3 months)