A Phase IIIb Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic 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
- •Histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease
- •No prior systemic treatment for metastatic disease
- •Adjuvant therapy ≥6 months prior to study entry with no residual toxic effects
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- •Life expectancy ≥12 weeks
- •Adequate hematologic, hepatic, and renal function
- •Negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential
排除标准
- •Unstable systemic disease
- •Prior systemic human epidermal growth factor receptor 1 (HER1) or epidermal growth factor receptor (EGFR) inhibitors
- •Other malignancy within 5 years prior to study entry
- •Significant opthalmologic abnormality
- •Inability to take oral medication
- •Need for IV alimentation
- •Prior surgery affecting absorption
- •Active peptic ulcer disease
- •Nursing mothers
研究组 & 干预措施
Erlotinib + Gemcitabine
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
干预措施: Erlotinib (Drug)
Erlotinib + Gemcitabine
Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Up to approximately 40 months (assessed continuously during treatment)
An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.
次要结局
- European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores(Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study))
- Overall Survival (OS)(Up to approximately 40 months (assessed continuously through end of study))
- Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)(Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study))
- Progression-Free Survival (PFS) According to RECIST(Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study))
- Percentage of Participants Who Died(Up to approximately 40 months (assessed continuously through end of study))