NCT00846443Unknown1 期
A Phase I Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer.
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities per protocol
研究概览
简要总结
The purpose of this study is to determine the recommended dose of pemetrexed and the maximum tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the patients with local advanced non-small cell lung cancer.
详细描述
This study was conducted to explore the feasibility of concurrent chemoradiation therapy with pemetrexed, cisplatin and radiotherapy in unresectable local advanced non-small cell lung cancer. We will perform the dose escalation of pemetrexed to determine if full dose (500mg/m2) of pemetrexed could be administrated concurrently with cisplatin and conventional dose radiotherapy (66Gy) firstly. Secondly, radiation dose will be escalated to determine the maximum tolerated dose (MTD) of radiotherapy when administered concurrently with full dose pemetrexed and cisplatin.
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
- •Age ≧18 years.
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •Patients with histologically or cytological-proven non-small cell lung cancer.
- •Stage IIIA or IIIB, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- •Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- •Weight loss ≦ 5% in the previous six months.
- •Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- •Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- •Patients must sign a study-specific informed consent form prior to study entry.
排除标准
- •Undifferentiated small cell carcinoma, any stage.
- •Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- •Stage IV.
- •Age <18 years.
- •Performance status ≧2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- •Patient has previously had thoracic radiation therapy.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- •Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- •History of significant neurological or mental disorder, including seizures or dementia.
- •Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a patient is taking an NSAID (Cox-2 inhibitors included) or salicylate with a long half-life (e.g. naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib) it should not be taken 5 days before, the day of, and 2 days after the dose of pemetrexed.
- •Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
- •Pregnant or lactating females.
结局指标
主要结局
Dose-limiting toxicities per protocol
时间窗: every 3 months from the end of treatment to 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and RadiotherapyCarcinoma, Small CellSmall Cell Lung CancerSCLCNCT00447421Eli Lilly and Company9
撤回
1 期
Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural MesotheliomaMalignant Pleural MesotheliomaNCT02639767Memorial Sloan Kettering Cancer Center
已完成
2 期
A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung CancerNon Small Cell Lung CancerNCT01165021Eli Lilly and Company19
已完成
1 期
Pemetrexed (Alimta) in Patients With Head and Neck Squamous Cell CancerHead and Neck CancerNCT00507858M.D. Anderson Cancer Center36
已完成
1 期
A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung CancerNon Small Cell Lung CancerNCT01189968OncoMed Pharmaceuticals, Inc.50