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

UMIN ID: C000000281

Registered date:14/11/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced Non-small Cell Lung Cancer
• Date of first enrollment: 2005/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: The Tokyo Cooperative Oncology Group
• Source(s) of Monetary Support: The Tokyo Cooperative Oncology Group