NCT00948935已完成2 期
Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
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
- 35
- 试验地点
- 1
- 主要终点
- Progression Free Survival Rate at Five Months
研究概览
简要总结
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.
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
- •histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
- •measurable disease
- •available tumor tissue for investigational immunohistochemical evaluations
- •ECOG PS 0-2
- •No prior chemotherapy, biologic therapy or radiation therapy
- •Age Eighteen and older
- •Lab values per protocol
排除标准
- •Life expectancy less than three months
- •Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
- •Prior therapy, which affects or targets the EGF pathway
- •Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- •Recovery from major surgery within three weeks of the start of study treatment
研究组 & 干预措施
Chemotherapy
Experimental
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
干预措施: Gemcitabine, Irinotecan, Panitumumab (Drug)
结局指标
主要结局
Progression Free Survival Rate at Five Months
时间窗: 5 months
次要结局
- Response Rate From Combination Chemotherapy(5 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder CancerBladder CancerNCT01916109Memorial Sloan Kettering Cancer Center4
已完成
2 期
Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder CancerUrinary BladderBladder CancerNCT00847015Memorial Sloan Kettering Cancer Center18
已完成
2 期
Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic CancerPancreatic CancerNCT00696696NYU Langone Health45
已完成
2 期
Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00401128The Cleveland Clinic9
已完成
2 期
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal CancerFallopian Tube CancerPeritoneal CancerOvarian CancerNCT00267696Ohio State University Comprehensive Cancer Center45