Phase II Trial of Bevacizumab in Combination With Gemcitabine and Carboplatin in Patients With Newly Diagnosed Non-Small Cell Lung Cancer (Excluding Squamous Cell Carcinoma)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
A multi-center study of bevacizumab in combination with gemcitabine and carboplatin as treatment for newly-diagnosed advanced non-small cell lung cancer (NSCLC).
详细描述
This is a open-label, phase 2, single-arm, multi-center study of bevacizumab combined with gemcitabine and carboplatin. This treatment is for newly-diagnosed advanced non-small cell lung cancer (NSCLC), excluding squamous cell carcinoma. All subjects will receive 15 mg/kg bevacizumab every 3 weeks cycle, 1000 mg/m² of gemcitabine on day 1 and 8 every 3 weeks cycle and carboplatin (AUC= 5 ) every 3 weeks. Carboplasm will be administered 1 hour prior to the gemcitabine infusion, bevacizumab will be administered 1 hour following chemotherapy infusion.
Subjects will receive a maximum of 6 cycles of chemotherapy, but treatment with bevacizumab may continue as long as patients have no evidence of progressive disease and no significant treatment-related toxicities.
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
- 未提供
排除标准
- •Prior systemic treatment for advanced NSCLC (one prior regimen of up to 4 cycles of neoadjuvant or adjuvant therapy for early stage disease will be allowed, if completed at least 6 months prior to study entry)
- •Known brain metastases
- •Prior treatment with bevacizumab
- •History of allergic reactions
- •Sensitivity attributed to compounds of similar chemical or biologic composition to bevacizumab
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study
- •Concomitant chemotherapy, radiotherapy, or investigational agents
- •Evidence of bleeding diathesis
- •Coagulopathy
- •Use of anti-coagulant agents including warfarin, heparin, aspirin, NSAIDs
- •Lactating
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- •Minor surgical procedures within 7 days prior to day 0
- •Fine needle aspirations within 7 days prior to day 0
- •Core biopsies within 7 days prior to day 0
- •Urine protein: creatinine ratio ≥ 1.0 at screening
- •History of abdominal fistula within 6 months prior to Day 0
- •Gastrointestinal perforation within 6 months prior to Day 0
- •Intra-abdominal abscess within 6 months prior to Day 0
- •Serious, non-healing wound
- •Bone fracture
- •Lung carcinoma of squamous cell histology
- •Any histology in close proximity to a major vessel
- •Significant cavitation as assessed by treating investigator in consultation with an attending radiologist
- •History of hemoptysis (bright red blood of 1/2 teaspoon or more)
- •Blood pressure of > 150/100 mmHg
- •Unstable angina
- •New York Heart Association (NYHA) Grade 2 or greater congestive heart failure
- •History of myocardial infarction within 6 months
- •History of stroke within 6 months
- •Clinically significant peripheral vascular disease
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Another active malignancy except for non-melanoma skin cancers
- •Inability to comply with study and/or follow-up procedures
研究组 & 干预措施
Bevacizumab + carboplatin + gemcitabine
Bevacizumab in combination with carboplatin and gemcitabine:
•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.
Carboplatin was administered before the gemcitabine infusion:
•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles
Bevacizumab was administered 1 hour after end of all chemotherapy infusions:
•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
干预措施: Bevacizumab (Drug)
Bevacizumab + carboplatin + gemcitabine
Bevacizumab in combination with carboplatin and gemcitabine:
•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.
Carboplatin was administered before the gemcitabine infusion:
•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles
Bevacizumab was administered 1 hour after end of all chemotherapy infusions:
•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
干预措施: Gemcitabine (Drug)
Bevacizumab + carboplatin + gemcitabine
Bevacizumab in combination with carboplatin and gemcitabine:
•Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles.
Carboplatin was administered before the gemcitabine infusion:
•Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles
Bevacizumab was administered 1 hour after end of all chemotherapy infusions:
•Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 18 months
Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.
次要结局
- Response Rate (CR + PR + SD)(6 weeks)
- Stable Disease (SD)(6 weeks)
- Overall Survival (OS) at 24 Months(24 months)
- Overall Survival (OS)(36 months)
- Partial Response (PR)(6 weeks)
- Complete Response (CR)(6 weeks)
- Time-to-First Event(18 months)
- Overall Survival (OS) at 12 Months(12 months)
研究者
Heather Wakelee
Associate Professor of Medicine (Oncology)
Stanford University