Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- reduction of circulating tumor cells
研究概览
简要总结
Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC
详细描述
A multicenter single arm phase II trial. 40 patients with pathology proven stage I-IIIA NSCLC that are eligible for resection will be enrolled in this study. All patients will receive one dose of cetuximab prior to surgery. Blood will be drawn on multiple timepoints to assess te amount of circulating tumor cells
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
- •18 years or older
- •Presence of surgically resectable NSCLC, stage I-IIIA, with curative intent surgery planned.
- •≥10 EGFR+EpCAM+ cells detected in the baseline blood sample.
- •Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug
排除标准
- •Chemotherapy or other anti-cancer therapy including radiotherapy during the study or within 4 weeks prior to the start of the study.
- •Prior anti-EGFR mAb therapy
- •Other currently active malignancy
- •Immunosuppressive drugs during the study or within 4 weeks prior to the start of te study
- •Expected adverse reactions/allergies or study medication
- •Mental disorder/unable to give informed consent
- •Pregnancy or breast-feeding patients
- •Significant skin condition interfering with treatment
- •Major surgery within 28 days before start of study.
- •Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
- •Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
研究组 & 干预措施
Single dose cetuximab prior to surgery
A single dose of cetuximab, 400mg/m2, will be administered 72 to 48 hours prior to surgery
干预措施: Cetuximab (Drug)
结局指标
主要结局
reduction of circulating tumor cells
时间窗: From date of registration until CTC measurement at 3 months after surgery.
The primary objective of this study is to determine whether a single neoadjuvant dose of cetuximab (anti-EGFR mAb) - administered 72 to 48 hours prior to surgery - will reduce the number of CTCs in patients. The reduction of CTCs will be expressed in percentage as more or less than 50% changed from baseline.
次要结局
- disease free survival(From date of surgery to until the date of first documented progression or date of death from any cause.)
- safety(From date of registration until CTC measurement at 3 months after surgery.)
- the reduction of CTC's in percentage as a continuous variable(From date of registration until CTC measurement at 3 months after surgery.)
- plasma ability killing tumor cells(From date of registration until CTC measurement at 3 months after surgery.)