unresectable non-small cell lung cancer
Conditions
Interventions
To determine recommended dose of S-1 and vinorelbine in phase I study, and to evaluate safety and efficacy of the combination of vinorelbine and S-a in patients with advanced non-small cell lung cance
Sponsors
Tottori University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histlogical or cytological diagnosis of non-small cell lung cancer 2. Unresectable 3. Have measurable lesions 4. No prior chemotherapy exclusing gefitinib of erlotinib 5. ECOG Performance status (PS) 0 to 1 6. Life expectancy of more than three months 7. patients aged 20 years of older 8. Have adequate function of maijor organs(bone marrow, liver, kidneys) 9. Oral intake 10. normal electrocardiogram 11. Provided written consent in person for participation in this study
Exclusion criteria
Exclusion criteria: 1. Patient with need of procedure for pleural effusion 2. Patient with need of drainage procedure for cardiac effusion 3. Patient with symptomatic brain metastasis 4. Patient with severe complications 5. Patient with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray 6. Female patient in or having achance or planning of pregnancy or breast feeding 7. Male patient in plannning to impregnate 8. Patient with active multiple cancers 9. Patient with history of drug hypersensitivity 10. Patient with history of hypersensitivity against vinorelbine or other vinca alkaloids 11. Patient with history of hypersensitivity against TS-1 or pyrimidine fluoride 12. Being treated with other pyrimidine fluoride 13. Being treated with flucytosine 14. Any patient judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I study: recommended dose Phase II study: progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, Overall survival, Response rate, Safety | — |
Countries
Japan
Contacts
Public ContactTadashi Igishi
Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology
Outcome results
None listed