NCT00694603终止2 期
A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway
Lecia V. Sequist3 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006年9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
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Response Rate by CT Scan Using RECIST Criteria
研究概览
简要总结
The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.
详细描述
- Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.
- The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.
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
- •Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC
- •Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway
- •Measurable disease, as defined by RECIST criteria
- •Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable
- •Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
- •ECOG Performance Status 0-2
- •18 years of age or older
- •Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
- •Bone marrow function, renal function, hepatic function as outlined in protocol
排除标准
- •Women who are pregnant of breastfeeding
- •Active concurrent malignancy
- •Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
- •Significant history of uncontrolled cardiac disease
- •Uncontrolled seizure disorder, or active neurological disease
- •Prior severe infusion reactions to a monoclonal antibody
- •Prior chemotherapy regimen within 21 days prior to study entry
- •Any EGFR tyrosine kinase inhibitor within 14 days of study entry
- •Radiation therapy within 14 days prior to the first infusion of cetuximab
- •Acute hepatitis or known HIV
- •Active or uncontrolled infection
- •Any concurrent chemotherapy or any other investigational agent(s)
研究组 & 干预措施
Cetuximab
Experimental
400mg/m2 IV x 1 and then 250mg/m2 IV weekly
干预措施: Cetuximab (Drug)
结局指标
主要结局
Response Rate by CT Scan Using RECIST Criteria
时间窗: 8 weeks
次要结局
- Progression-free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
研究者
Lecia V. Sequist
Overall PI
Massachusetts General Hospital
研究点 (3)
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