Phase II Study of Docetaxel and TS-1 Combination Therapy for Outpatients with Relapsed or Refractory Non-small Cell Lung cancer

UMIN ID: UMIN000000501

Registered date:12/10/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Relapsed or Refractory Non-small Cell Lung Cancer
• Date of first enrollment: 2006/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel is intravenously at 40 mg/m2 on day1, and TS-1 is orally given at 80mg/m2/day from day1 to 14 every 3weeks.

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: overall survival, progression-free survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Active ineterstitial pneumonitis 2) History of using TS-1 or docetaxel 3) Active infectious disease 4) Active hepatitis or hepatocirrhosis 5) Active concomitant malignancy 6) Uncontrollable diabetes 7) Serious cardiac disease 8) Psycologic illness 9) Other severe complications 10) Pleural or pericardial effusion, or ascites requiring treatment 11) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 12) Regular use of warfarin 13) Regular use of fenitoin or frucitocin 14) High fever 15) Clinical symptom of brain metastases 16) Serious nephropathy and/or edema 17) Regular use of steroid 18) Medical history of serious allergy reactions to any drug 19) Inappropriate patients for this study judged by the physicians.

Related Information

• Primary Sponsor: Outpatient Oncology Unit Kyoto University Hospital
• Source(s) of Monetary Support: None