NCT00268411Unknown3 期
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
GERCOR - Multidisciplinary Oncology Cooperative Group30 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 30
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
Secondary
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the pancreas
- •Metastatic disease
- •Measurable disease (primary tumor or metastasis)
- •At least 1 cm in diameter by spiral CT scan
- •No ampulla of Vater carcinoma or biliary adenocarcinoma
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- •Life expectancy more than 12 weeks
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Alkaline phosphatase < 5 times normal
- •Bilirubin < 1.5 times normal
- •Creatinine < 1.5 times normal
- •No pre-existing neuropathy
- •No unstable or uncontrolled pain
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No serious cardiovascular disease
- •No serious respiratory disease
- •No uncontrolled or persistent hypercalcemia
- •No psychological, familial, social, or geographical condition that would preclude study treatment
- •No other active malignancy
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy
- •No concurrent corticosteroids
排除标准
- 未提供
结局指标
主要结局
Objective response rate
次要结局
- Clinical benefits and tolerability
- Progression-free and overall survival
研究者
研究点 (30)
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