NIPH Clinical Trials Search

UMIN ID: C000000281

Registered date:14/11/2005

Phase I/II Study of Docetaxel and S-1 Combination Therapy for Advanced Non-small Cell Lung Cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAdvanced Non-small Cell Lung Cancer
Date of first enrollment2005/04/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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.


Primary OutcomePhase 1 study:to establish MTD and to determine the RD Phase 2 study:Response rate
Secondary OutcomePhase 1 study:Safety,S-1compliance Phase 2 study:Safety,Survival,Progression free-survival,S-1compliance

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1)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.

Related Information


public contact
Address Japan
Affiliation Nippon Medical School Department of Internal Medicine/Infection and Oncology
scientific contact
Name Keiichi Nagao
Address 1-33 Yayoi-cho Inage-ku Chiba-shi Chiba 263-0022 Japan Japan
Affiliation Chiba University Safety and Health Organization