Non-small cell lung cancer
Conditions
Interventions
Patients in group A will receive an infusion of gemcitabine on days 1 and 8.
Patients in group B will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carbo
Sponsors
Niigata Lung Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in this trial had histologically or cytologically confirmed stage IIIb or IV NSCLC. Patients with stage IIIb disease who were not candidates for thoracic radiation and those with stage IV disease were eligible, if they had not received previous chemotherapy, had measurable disease, and had a life expectancy of at least 3 months. Additional entry criteria were age 75=< years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 4,000/mL, neutrophil count > 2,000/mL, 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), and pulmonary (PaO2 > 60 torr) functions.
Exclusion criteria
Exclusion criteria: Patients were excluded if they had any active concomitant malignancies, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, 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,safety, toxicity, QOL | — |
Countries
Japan
Contacts
Public ContactHirohisa Yoshizawa
Niigata University Medical and Dental Hospital Bioscience Medical Research Center
Outcome results
None listed