A Phase II Trial of Pemetrexed, Gemcitabine, and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIB/IV Non- Squamous, Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of pemetrexed disodium, gemcitabine hydrochloride, and bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell non-small cell lung cancer.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
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
- 未提供
研究组 & 干预措施
Bevacizumab, gemcitabine hydrochloride
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
干预措施: bevacizumab (Biological)
Bevacizumab, gemcitabine hydrochloride
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
干预措施: gemcitabine hydrochloride (Drug)
Bevacizumab, gemcitabine hydrochloride
Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days
Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.
干预措施: pemetrexed disodium (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 12 months
RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
次要结局
- Number of Participants With Response(Every 8 weeks, for up to 54 months)
- Number of Participants With Grade 3 or Grade 4 Toxicity(Every two weeks, for up to 54 months)
- Overall Survival(Every 8 weeks, for up to 54 months)
- Time to Treatment Failure(Every 8 weeks, for up to 54 months)
研究者
Antoinette J. Wozniak
Principal Investigator
Barbara Ann Karmanos Cancer Institute