NCT00524017已完成2 期
Phase II Study of Single-Agent Cetuximab for Treatment of High-Risk Pre-malignant Upper Aerodigestive Lesions
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins19 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2007年5月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 19
- 主要终点
- Number of Participants With Objective Response Based on Histologic Grade
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block abnormal cell growth in different ways. Some block the ability of abnormal cells to grow and spread. Others find abnormal cells and help kill them or carry cell-killing substances to them.
PURPOSE: This randomized phase II trial is studying how well cetuximab works in treating patients with precancerous lesions of the upper aerodigestive tract.
详细描述
OBJECTIVES:
Primary
- To determine the histologic response rate in patients with high-risk, premalignant lesions of the upper aerodigestive tract treated with cetuximab.
Secondary
- To determine the clinical response rate in these patients.
- To determine if patterns of epidermal growth factor receptor (EGFR) component expression are altered in these patients.
- To determine the change in status of genetic alterations, including loss of heterozygosity, in these patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Objective Response Based on Histologic Grade
时间窗: 8 weeks
Histologic downgrade by at least one grade of dysplasia (e.g Severe to Moderate).
次要结局
- Survival(Up to year 5 years post-treatment)
- Status of Epidermal Growth Factor Receptor (EGFR) Pathway Components and Molecular Alterations in Pre-treatment Biopsies(Baseline (pre-treatment))
- Status of EGFR Pathway Components and Molecular Alterations in Post-treatment Biopsies(At 8 weeks post-treatment)
- Lesion Recurrence(Up to year 5 years post-treatment)
- Number of Participants With Objective Response Based on Clinical Assessment(8 weeks)
研究者
研究点 (19)
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