EUCTR2006-003086-14-IT进行中（未招募）不适用
A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel XRP9881 at 90 mg/m2 every 3 weeks Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen - PAPRIKA
sanofi-aventis recherche developpement0 个研究点目标入组 400 人开始时间: 2007年3月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Cytologically or histologically confirmed evidence of epithelial cancer adenocarcinoma of the exocrine pancreas. Advanced disease defined as non operable in a curative intent, locally recurrent or metastatic disease. Patients with non-measurable disease as per RECIST criteria are eligible. Patient must be previously treated with a systemic gemcitabine based regimen given as adjuvant chemotherapy disease free interval must be less than 6 months or as therapy for advanced disease. Patients treated in addition with prior chemo-radiation to the primary pancreatic tumor, in which the chemotherapeutic agent was used as a radio-sensitizing agent, are eligible. /
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •More than one previous chemotherapy regimen for advanced pancreatic disease. ECOG performance status PS of 3-4. History of hypersensitivity grade 3 to taxanes, Polysorbate-80, or to compounds with similar chemical structures.History of hypersensitivity to fluoropyrimidines. Known dihydropyrimidine dehydrogenase deficiency. Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization
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