extensive disease small-cell lung cancer
Conditions
Interventions
single-arm phse II study. Patients receive irinotecan 60 mg/m2 intravenously on day 1 and 8 plus cisplatin 60 mg/m2 intravenously on day 1 every three weeks for three cycle, then amrubicin 40 mg/m2 in
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) small-cell lung cancer; 2) extensive disease; 3) Eastern Cooperative Oncology Group performance status of 0 or 1; 4) age of 20 to 70 years; 5) no prior chemotherapy; 6) neither palliative radiation nor surgery within 14 days; 7) measurable lesions; 8) a life expectancy of at least two months; 9) adequate organ fanctions; and 10) written informed consent.
Exclusion criteria
Exclusion criteria: 1) symptomatic brain metastases; 2) pleural or pericardial effusion requiring drainage; 3) interstitial pneumonitis or pulmonary fibrosis; 4) active infection; 5) watery diarrhea, paralysis of the intestine, or ileus; 6) active gastric or duodenal ulcer; 7) continuous administration of steroids or non-steroidal anti-inflammatory drugs; 8) uncontrolled diabetes mellitus or angina pectoris; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) pregnancy or lactation; and 12) unsuitable for entry to the study, decided by a medical oncologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: response rate. Secondary endpoints: overall survival, time to progression, and toxicity. | — |
Countries
Japan
Outcome results
None listed