Advanced Non-small Cell Lung Cancer
Conditions
Interventions
Docetaxel is intravenously from 40 mg/m2 and step up to 50,60 mg/m2 on day1, and oral administration, of S-1 is given from 80mg/day and is invented to 100, 120 mg/day from day1 to 14 every 3weeks.
Sponsors
The Tokyo Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed NSCLC 2)Measurable lesions (RECIST) 3)Stage IIIB or IV patients excluding applying radiotherapy 4)No prior therapy including operation radiation chemotherapy or BRM 5)P.S.(ECOG) 0-2 6)Age ranging from 20-74 years 7)Sufficient organ functions 8)Expected survival over 3 months 9)Provided written informed consent.
Exclusion criteria
Exclusion criteria: 1)Serious infectious disease 2)Patient receiving flucytosine 3)Apparent ineterstitial pneumonia or pulmonary fibrosis 4)Medical history of allergy or hypersensitivity reactions to S-1 or any drug containing polysorbate 80 5)Edema need for treatment 6)Pleural or pericardial effusion requiring treatment 7)Patient intermittent oxygen supply 8)Serious concomitant disease 9)Cardiac infarction within 6 month 10)Supra vena cava syndrome patient 11)Pregnant or lactation women, or women with known or suspected pregnancy. 12)Man who wont let to pregnancy 13)Clinical symptom of brain metastases 14)Medical history of serious allergy reactions to any drug 15)Inappropriate patients for this study judged by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 study:to establish MTD and to determine the RD Phase 2 study:Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 study:Safety,S-1compliance Phase 2 study:Safety,Survival,Progression free-survival,S-1compliance | — |
Countries
Japan
Outcome results
None listed