None listed
Conditions
Interventions
Drug : The subjects will receive 500mg/m2 pemetrexed intravenously q 3 week until disease progression or development of intolerable toxicity.
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 ( 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diseas Free survival at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Best Response rate (Complete Response/Partial Response);Diseae control rate (Complete response/Partial Response, Stable Disease);Overall Survival Duration | — |
Countries
Korea, Republic of
Contacts
Public ContactHyejin Won
National Cancer Center
Outcome results
None listed