Non-small cell lung cancer
Conditions
Interventions
Docetaxel 60mg/m2, CBDCA AUC 5 every 3 weeks
Sponsors
Niigata Lung Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 histologically or cytologically confirmed NSCLC 2 recurrent post operative patients 3 measurable disease, and had 4 a life expectancy of at least 3 months. 5 20>=age >75 years 6 performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale 7 adequate organ function adequate bone marrow (leukocyte count 12,000>= >=4,000/mm3, neutrophil count > =2,000/mm3, hemoglobin concentration > =9.5g/dL, platelet count >= 100,000 /mL), kidney (creatinine <= 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =100, total bilirubin <= 2.0 mg/dL)
Exclusion criteria
Exclusion criteria: 1 active concomitant malignancies,infections 2 symptomatic brain metastases 3 past history of severe allergic reactions to drugs 4 interstitial pneumonia identified by chest X-ray 5 bone metastasis or hypercalcemia required immediate treatment 6 other serious complications, such as uncontrolled angina pectoris,myocardial infarction, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, overall survival, safety, QOL, relationship between response and expression of type III tublin, ERCC1, RRM1. | — |
Countries
Japan
Contacts
Public ContactHirohisa Yoshizawa
Niigata University Medical and Dental Hospital Bioscience Medical Research Center
Outcome results
None listed