Extensive small-cell lung cancer
Conditions
Interventions
Cisplatin 60 mg/m2 day 1 and irinotecan 60 mg/m2 days 1 and 8 were administered every 3 weeks for four cycles.
Cisplatin 60 mg/m2 day 1, irinotecan 60 mg/m2 days 1 and 8 and etoposide 50 mg/m2 days 1-
Sponsors
Division of Medical Oncology, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) a histological or cytological diagnosis of SCLC; 2) no prior treatment; 3) measurable disease; 4) extensive disease, defined as having distant metastasis or contralateral hilar lymph node metastasis; 5) performance status of 0 to 2; 6) predicted life expectancy of 3 months; 7) adequate organ function as documented by a WBC count 4,000/micro L, neutrophil count 2,000/ micro L, hemoglobin 9.5 g/dl, platelet count 100,000/ micro L, total serum bilirubin 1.5 mg/dl, hepatic transaminases 100 IU/l, serum creatinine 1.2 mg/dl, creatinine clearance 60 ml/min, and PaO2 60 Torr; and 8) written informed consent.
Exclusion criteria
Exclusion criteria: 1) uncontrollable pleural, pericardial effusion or ascites; 2) symptomatic brain metastasis; 3) active infection;4) contraindications for the use of irinotecan, including diarrhea, ileus, interstitial pneumonitis and lung fibrosis; 5) synchronous active malignancies; 6) serious concomitant medical illness, including severe heart disease, uncontrollable diabetes mellitus or hypertension; or 7) pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median survival time | — |
Countries
Japan
Contacts
Public ContactIkuo Sekine
Lung Cancer Study Group Division of Medical Oncology, National Cancer Center Hospital
Outcome results
None listed