Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.
详细描述
There is no definite evidence of a superior therapy for advanced non-small cell lung cancer in elderly patients. With the exception of one known study, single agent erlotinib has not been studied exclusively in the elderly and the combination of erlotinib and bevacizumab has never been studied exclusively in the treatment naive elderly. This is an important population that needs less toxic therapies.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy.
- •ECOG PS 0-1
- •70 years of age or older
- •Must have measurable disease
- •ANC > 1500, platelets > 100,000
- •Total bilirubin </= 1.5, SGOT * SGPT < 5 x ULN
- •Able and willing to swallow and absorb oral medication
- •Able and willing to sign consent
- •Request archival diagnostic tissue for EGFR expression but not required
排除标准
- •Proteinuria as demonstrated by UPC ratio >/= 1.0
- •Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide)
- •Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic)
- •History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation
- •Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment.
- •Current, ongoing treatment with full dose warfarin or equivalent
- •Current(within 10 days)use of aspirin (> 325mg/day) or other NSAID with antiplatelet activity
- •History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD
- •Known CNS disease except for treated brain mets.
- •Squamous cell histology
- •Blood pressure > 150/100 that cannot be ameliorated with standard anti-hypertensives
- •History of hypertensive crisis or hypertensive encephalopathy
- •NYHA grade II or > CHF
- •History of MI within 6 months of enrollment
- •Major surgery, open biopsy, significant trauma within 28 days of enrollment
- •Pregnancy, lactation
- •Abdominal or other fistula, abcess, perforation
研究组 & 干预措施
Bevacizumab & Erlotinib
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
干预措施: bevacizumab (Drug)
Bevacizumab & Erlotinib
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 3 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
未报告次要终点