A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.
详细描述
This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- •Predicted life expectancy of >= 12 weeks
- •Previous surgery
- •Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
- •No prior therapy for pancreatic cancer
- •Adequate organ and marrow function
- •Absolute neutrophil count >= 1.5 x 10^9/L
- •Platelets >= 100 x 10^9/L
- •Total bilirubin <= institutional upper limits of normal
- •AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal
- •Serum creatinine <= 1.5 x upper limits of normal
- •Negative pregnancy test
- •Informed consent
- •Patient must agree not to smoke while on study
排除标准
- •Significant history of cardiac disease unless the disease is well controlled
- •Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
- •History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
- •History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
- •Pregnant or breast-feeding females
- •Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
- •History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs
研究组 & 干预措施
erlotinib, gemcitabine, nab-paclitaxel
Patients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.
干预措施: erlotinib (Drug)
erlotinib, gemcitabine, nab-paclitaxel
Patients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.
干预措施: gemcitabine (Drug)
erlotinib, gemcitabine, nab-paclitaxel
Patients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Monthly (to a maximum of 12 months)
次要结局
- Safety of drug combination assessed through dose limiting toxicities (DLTs)(1 month)
- Safety of drug combination assessed through Adverse Events (AEs)(Monthly (to a maximum of 12 months))
- Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)(Days 29 (Cycle 2, Day 1) and 30)
- Objective Response Rate(Monthly (to a maximum of 12 months))
- Progression Free Survival (PFS)(Monthly (to a maximum of 12 months))
- Overall Survival(Monthly (to a maximum of 12 months))