Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically confirmed NSCLC, who had not previously received any chemotherapy or radiotherapy, and relased after thoracic surgery. Other criteria included: 1) age >20 and <75 years; 2) Eastern Clinical Oncology Group (ECOG) performance status 0&#8211;1; 3) unresectable stage IIIb or IV disease; 4) adequate bone marrow function (neutrophil count >2 x 103/&micro;l, hemoglobin 10 g/dl, platelet count > 10 x 10 4/&micro;l), normal hepatic function (total bilirubin level < 1.5 mg/dl and AST < twice the upper normal limit), and renal function (serum creatinine <1.2 mg/dl, creatinine clearance > 60 ml/min). PO2 >60 torr.
Exclusion criteria
Exclusion criteria: 1) interstitial pneumonia on chest XP, 2) pleural or pericardial effusion that required drainage, 3)neuropathy grade over 2, 4) systemic edema grade over 2, 5) severe heart disease, hypertension, DM, 6) active infection 7) active brain metastasis, or 8) pregnancy. 9) double cancers, 10) past history of hypersensitivity to drugs,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the recommended dose of ALIMTA/CDGP combined chemotherapy | — |
Countries
Japan