NCT00768131撤回2 期
A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab
研究概览
简要总结
The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
- •No prior chemotherapy or anti-EGFR targeted therapy
- •Sufficient tumor material for FISH testing
- •Measurable disease (RECIST)
- •ECOG performance status 0 or 1
排除标准
- •Symptomatic or uncontrolled CNS metastases
- •Inadequate hematologic function defined as ANC < 1,500/mm3, platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dl
- •Inadequate hepatic function defined as total bilirubin > 1.25 x ULN, AST level > 1.5 x ULN, or alkaline phosphatase > 5.0 x ULN
- •Inadequate renal function defined by a serum creatinine level > 1.5 x ULN
研究组 & 干预措施
A1 FISH (+)
Experimental
干预措施: Cetuximab (Drug)
A1 FISH (+)
Experimental
干预措施: Paclitaxel (Drug)
A1 FISH (+)
Experimental
干预措施: Carboplatin (Drug)
B1 FISH (+)
Active Comparator
干预措施: Paclitaxel (Drug)
B1 FISH (+)
Active Comparator
干预措施: Carboplatin (Drug)
A2 FISH (-)
Experimental
干预措施: Cetuximab (Drug)
A2 FISH (-)
Experimental
干预措施: Paclitaxel (Drug)
A2 FISH (-)
Experimental
干预措施: Carboplatin (Drug)
B2 FISH (-)
Active Comparator
干预措施: Paclitaxel (Drug)
B2 FISH (-)
Active Comparator
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab
时间窗: Every 6 weeks
次要结局
- Disease control(Every 6 weeks)
- Tumor response(Every 6 weeks)
- Overall survival (OS)(Every 4 months after subject off-treatment until 1 year after LPLT)
- Duration of Response(Every 6 weeks)
- Safety & exploratory biomarker analysis(Every 3 weeks)
研究者
研究点 (1)
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