An Open Label Study to Establish the Preferred Dose and to Assess Safety and Overall Response Rate of Avastin in Combination With Concomitant Thoracic Radiation and Chemotherapy (Cisplatin and Etoposide) in Locally Advanced Unresectable Non-squamous Non-small Cell Lung Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This single arm study will evaluate the feasibility of treatment with 2 dose levels of Avastin in combination with concurrent thoracic radiation and chemotherapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer. Two cohorts of patients will receive 3 cycles of Avastin treatment (7.5mg/kg and 15mg/kg iv every 3 weeks, respectively), concurrently with thoracic radiation and chemotherapy (cisplatin and etoposide). Once a preferred dose has been established, this dose will be applied to a 3rd cohort, who will then receive maintenance treatment with Avastin as a single agent for 6 additional cycles. The anticipated time on study treatment is <3 months for cohorts 1 and 2, and 3-12 months for cohort 3, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients, >= 18 years of age;
- •non-squamous non-small cell lung cancer, locally advanced and unresectable;
- •ECOG performance status 0 or 1;
- •no prior thoracic or head and neck radiation;
- •no prior surgical resection for current lung cancer.
排除标准
- •malignancies other than non-small cell lung cancer within 2 years prior to inclusion, except for basal cell cancer of the skin, squamous cancer of the skin, or cancer in situ of the cervix;
- •prior systemic therapy for non-small cell lung cancer;
- •clinically significant cardiovascular disease;
- •history of >= grade 2 hemoptysis;
- •current or recent use of aspirin (>325mg/day) or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
研究组 & 干预措施
1
干预措施: etoposide (Drug)
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: cisplatin (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: Throughout Study
次要结局
- AEs, laboratory parameters(Throughout Study)
- Tumor response(Throughout Study)