NCT00085839已完成2 期
A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
OSI Pharmaceuticals19 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2004年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 19
- 主要终点
- Progression-free Survival
研究概览
简要总结
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
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
- 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
- •Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
- •No prior chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- •Clinically or radiologically measurable disease per RECIST criteria
排除标准
- •Gastro-intestinal abnormalities
- •Any concurrent anticancer therapy
- •Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
- •Other active malignancies
- •Uncontrolled brain metastases
- •Severe abnormalities of the cornea
- •Significant cardiac disease
研究组 & 干预措施
Erlotinib
Experimental
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
干预措施: Tarceva (Trademark) (erlotinib HCl, OSI-774) (Drug)
Standard Chemotherapy
Active Comparator
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
干预措施: Combination carboplatin and paclitaxel (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Until time of disease progression (maximum 5 months)
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
次要结局
- Overall Survival(From first study treatment until time of death (maximum 26.8 months))
- Best Tumor Response(While receiving study treatment (maximum 60 weeks))
研究者
研究点 (19)
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