A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 11
- 主要终点
- Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
研究概览
简要总结
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
详细描述
OUTLINE: This is a multi-center study.
Week 1 (day 1):
- Cetuximab 400mg/m2
Week 2 (Cycle 1, Day 1):
- Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.
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
- •Histologic or cytologic diagnosis of NSCLC
- •Recurrent or metastatic disease that is not amenable to curative therapyMeasurable disease according to RECIST
- •At least one prior platinum containing regimen for either locally advanced or metastatic disease
- •Prior chemotherapy must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen
- •Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period
- •Prior radiation therapy allowed to < 25% of the bone marrow
- •Negative pregnancy test
排除标准
- •No active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
- •No serious concomitant systemic disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.
- •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least 2 years.
- •No major thoracic or abdominal surgery within 30 days prior to being registered for protocol therapy.
- •No current breastfeeding
研究组 & 干预措施
Investigational Treatment
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
干预措施: Pemetrexed (Drug)
Investigational Treatment
Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab
时间窗: 12 months
The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab
Time To Progression (TTP)
时间窗: 24 Months
The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
次要结局
- Median Survival Time(24 Months)
- Toxicity and Safety Profile(12 months)
- Clinical Benefit Rate(12 months)
研究者
Nasser Hanna, M.D.
Sponsor-Investigator
Hoosier Cancer Research Network