KCT0003518招募中未知
Phase II study of pemetrexed in previously-treated patients with advanced squamous cell lung carcinoma having low level of thymidylate synthase
CC Hospital0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Age = 19 years.
- •2.Hitologically or cytologically confimed of squamous cell carcinoma non-small cell lung cancer
- •3.Advanced or recurrent NSCLC according AJCC-TNM stage IIIB or IV
- •4.Immunohistochemistry (IHC) staining TS expression negative (<10%)
- •5.Disease progressed after at least one systemic chemotherapy including platinum-based chemotherapy.
- •6.Measurable or Evaluable disease according to RECIST 1.1
- •7.ECOG performance status 0-2
- •8.Adequate hematological and biological function by follows.
- •-WBC count =2,000/?
- •-Hemoglobin =9.0 g/?
- •-Platelet =100,000/?
- •-Serum Creatinine=1.5 ?/? ?? creatinine clearance > 45 ?/min
- •-AST/AST =2.5 x upper limit of normal range (ULN)(If liver metastatis, =5 x ULN)
- •-Total bilirubin =2.0 x ULN)(If liver metastatis, =3 x ULN)
- •9.Written informed consent from patient or patient’s agent
排除标准
- •1.Chemotherapy, radiotherapy or surgery within the past 3 weeks prior to enrollment (Gamma knife or cyber knife within the past 2 weeks)
- •2.Active Brain or meningeal meatstasis with clinically significant neurological symptoms or sings. (except unless clinically significant neurological signs and symptoms are present and steroids are not required)
- •3.A history of other malignancies (excluding non-melanoma skin cancer, carcinoma in situe of the cervix, superficial bladder cancer and thyroid cancer)
- •Except there is no ongoing treatment within the past 3 years or if it has been without evidence of recurrence)
- •4.Clinically significant uncontrolled disease, as follows
- •-Uncontrolled DM
- •-Active infection requiring IV antibiotics
- •-Mental Illness/Social situation that may limit compliance with clinical trail requirements
- •5.Any of the following cardiac abnormality or historyw
- •-Uncontrolled HTN
- •- stable <40 beats/min. stable bradycardia
- •-Insertion pacemaker, defibrillatior
- •-Personal or family history of long QT syndrome, Grade 2 or 3 heart block.
- •-QT interval > 480 msec using fixed QTcF or QTcB method
- •-Clinically significant ECG abnormality.
- •-Myocardial infarction within 6 months prior to enrollment.
- •-Congestive heart failure, unstable angina – NYHA grade 3
- •6.Judgment by the investigator that the subject should not participate in the study due to the toxicity of the previous treatment
- •7.Previous treatment any investigational agents within 4 weeks prior to enrollemtns.
- •8.Women who are pregnancy or breast feeding
- •9.Males and females of reproductive potential who are not using and effective method of birth control.
- •10.Contraindication for Pemetrexed
研究者
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