non small cell lung cancer
Conditions
Interventions
TS1: 65 or 80 mg/body/day, orally 14 days, every 3 weeks Carboplatin: AUC 4.0, 5.0 or 6.0
Sponsors
Department of Medical Oncology, Kinki University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stage IIIB or IV NSCLC 2) No indication of curable chemoradiation 3) Chemonaive 4) At least one measurable lesion 5) 75 > Age > 20 years 6) Performance status (PS) of 0 to 1 7) Adequate main organ functions WBC > 4000/mm3 Plt > 100000/mm3 Hb > 9.0g/dl T-bil 60mmHg 8) No limitation of outpatients 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of active other malignancy 2) Severe heart disease (uncontrolled angina pectoris , myocardial infarction, heart failure within 3 months 3) Uncontrolled diabetes 4) Severe complication (infection, bowel obstruction, or hemorrhage etc.) 5) Intestinal pneumonia or lung fibrosis 6) Severe diarrhea 7) Massive pleural, cardiac, or abdominal effusion 8) Regular use of fenitoin, warfarin or frucitocin 9) Symptomatic brain metastasis 10) History of severe drug allergic reaction 11) History of bone marrow plantation or self peripheral blood stimulated transportation 12) Pregnant women or women willing child-bearing 13) Inadequate condition diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decision of the recommended dose of TS1 and carboplatin | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of dose limited toxicity and response and safety of the combination of TS1 and carboplatin | — |
Countries
Japan
Outcome results
None listed