Phase II Study of Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1 (Excision Repair Cross-complementation Group 1)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- 6 month overall survival
研究概览
简要总结
The goal of this clinical trial is to improve and personalize pancreatic cancer care to deliver the most effective therapy while avoiding unnecessary exposure to potential side effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts. The hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of ERCC1.
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
- •Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
- •Patients must not have had prior chemotherapy or biologic therapy for metastatic pancreatic cancer
- •Prior adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed but must have been administered > 6 months prior to registration
- •ECOG Performance Status of 0, 1, or 2
- •Adequate hematologic, hepatic and renal function
排除标准
- •Pregnant or nursing women
- •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years
- •Patients must not have known brain metastases
- •Any other condition that in the opinion of the Investigator may render the patient at excessive risk for treatment complications
研究组 & 干预措施
ERCC1 low expression
Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin
干预措施: gemcitabine and oxaliplatin (Drug)
结局指标
主要结局
6 month overall survival
时间窗: 6 months
次要结局
- Progression free survival(Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years)
- Overall survival(Assessments every 2 months until 2 years or death)
- Best confirmed response(Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years)
- Duration of overall response(Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years)