APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 37
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
详细描述
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 adenocarcinoma of the pancreas that is locally advanced or metastatic.
- •Life expectancy greater than or equal to 3 months.
- •Patients must have measurable disease by RECIST.
- •ECOG PS of 0, 1, or
- •Negative serum pregnancy test at the time of first dose for women of childbearing potential.
排除标准
- •Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
- •RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
- •Evidence of New York Heart Association class III or greater cardiac disease.
- •History of myocardial infarction, stroke, ventricular arrhythmia.
- •Symptomatic central nervous system metastases.
- •Pregnant or nursing women.
- •Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- •History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
- •Previous anti-EGFR kinase therapy.
研究组 & 干预措施
apricoxib + gemcitabine + erlotinib
400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
干预措施: gemcitabine (Drug)
apricoxib + gemcitabine + erlotinib
400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
干预措施: Erlotinib (Drug)
apricoxib + gemcitabine + erlotinib
400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
干预措施: apricoxib (Drug)
placebo + gemcitabine + erlotinib
placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
干预措施: gemcitabine (Drug)
placebo + gemcitabine + erlotinib
placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
干预措施: placebo (Drug)
placebo + gemcitabine + erlotinib
placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Randomization then every other cycle
Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
次要结局
- Overall Survival(Randomization then every other cycle)