Study of pemetrexed in previously-treated patients with advanced squamous cell lung carcinoma having low level of TS
- Conditions
- Neoplasms
- Registration Number
- KCT0003518
- Lead Sponsor
- CC Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diseas Free survival at 12 weeks
- Secondary Outcome Measures
Name Time Method Overall Best Response rate (Complete Response/Partial Response);Diseae control rate (Complete response/Partial Response, Stable Disease);Overall Survival Duration