Impact of Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer: A Study by the Hellenic Co-operative Oncology Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 主要终点
- Tumor response
研究概览
简要总结
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.
详细描述
In 2008, the Hellenic Co-operative Oncology group (HeCOG) initiated a randomized phase II study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy, with erlotinib given for twelve consecutive days either before (group A) or after (group B) docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. Docetaxel chemotherapy was considered one of the valid non-platinum containing therapeutic options at that time and today represents one of the approved second-line treatment options after failure of first-line platinum based chemotherapy. The trial was terminated early due to slow accrual after enrollment of 51 patients and was published in 2014, showing no clinically meaningful difference between the two treatment arms.
Based on the aforementioned trial population,a parallel radiological study was conducted, evaluating sequential tumor metrics on computed tomography performed at baseline and after each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib. Given the differential mechanism of action of these agents, it was hypothesized that the different parameters of radiological tumor response evaluation, namely the maximum diameter, tumor volume and tumor density, would respond differently for each therapeutic category (a chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). For bevacizumab, in particular, it was hypothesized that its unique mechanism of action, inducing central tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as compared to the other two agents. Herein the final results of this analysis are presented, showing the comparison of the three agents in terms of tumor response metrics, as evaluated in CT scans performed at baseline and after each cycle of treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
排除标准
- •Patients who have undergone complete tumor resection after responding to platinum based chemotherapy.
结局指标
主要结局
Tumor response
时间窗: Every 12 -16 weeks
Evaluation of response using RECIST 1.1 criteria (REF) was based on the measurement of a total of 5 measurable lesions.
次要结局
未报告次要终点
