small cell lung cancer
Conditions
Interventions
Topotecan: 0.6, 0.8, 1.0, 1.2 mg/m2, day 1-3, every 3 weeks Cisplatin: 25 mg/m2, day 1-3, every 3 weeks
Sponsors
Department of Medical Oncology, Kinki University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) SCLC 2) No prior treatment 3) Extended disease of limited disease with pleural effusion 4) age>=70 years,Performance status (PS) of 0 to 2 5) At least one measurable lesion 6) Adequate main organ functions 7) Estimation of at least 3 months survival 8) No limitation of use of topotecan and cisplatin 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1)Severe infection and complication (hemorrhage and heart disease etc.) 2)Intestinal pneumonia or lung fibrosis 3)Symptomatic brain metastasis 4)History of active other malignancy 5)History of severe drug allergic reaction 6)Pregnant women or women willing child-bearing 7)Men willing to have children 8)Uncontrolled diabetes 9)Uncontrolled pleural, cardiac, or abdominal effusion 10)Inadequate condition diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decision of the recommended dose of cisplatin and topotecan | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of dose limited toxicity and response and safety of the combination of topotecan and cisplatin | — |
Countries
Japan
Outcome results
None listed