NCT00261092已完成2 期
Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Overall response rate based on RECIST criteria
研究概览
简要总结
Primary objective:
- To evaluate overall response rate (based on RECIST criterion)
Secondary objective:
- To evaluate time to progression, clinical benefit, quality of life and safety
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
- •Histologically proven adenocarcinoma of the pancreas
- •Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
- •Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan)
- •No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
- •Karnofsky Performance Status (KPS) ≥60
- •No known Central Nervous System metastases
- •No sensory neuropathy at inclusion
- •Biological and hematological evaluation < 2 weeks prior to treatment administration:
- •Neutrophils ≥ 1500/ mm3
- •Platelets ≥ 100,000/mm3
- •Alkaline phosphatases< 5X ULN(upper Limits of Normal) and Bilirubin < 1.5X ULN
- •SGOT,SGPT <2.5 X ULN if no liver metastasis
- •SGOT,SGPT <5 X ULN if liver metastasis
- •Creatinine < 1.5 X ULN
- •Baseline imaging (CT scan or Magnetic Resonance Imaging) <3 weeks before treatment administration
- •Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
排除标准
- •Corticotherapy except for anti-emetic purpose
- •Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
- •Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
- •Uncontrolled or persistent hypercalcemia
- •History of significant neurologic or psychiatric disorders
- •Vater ampulomas and biliary tract adenocarcinomas
- •Other -non cured- malignancies
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Overall response rate based on RECIST criteria
次要结局
- Time to progression
- Overall survival
- Clinical benefit
- Quality of life
研究者
研究点 (1)
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