Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer

UMIN ID: C000000054

Registered date:04/09/2005

Basic Information

• Health condition(s) or Problem(s) studied: non small cell lung cancer
• Date of first enrollment: 2005/02/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): TS1: 65 or 80 mg/body/day, orally 14 days, every 3 weeks Carboplatin: AUC 4.0, 5.0 or 6.0

Outcome(s)

• Primary Outcome: Decision of the recommended dose of TS1 and carboplatin
• Secondary Outcome: Determination of dose limited toxicity and response and safety of the combination of TS1 and carboplatin

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) History of active other malignancy 2) Severe heart disease (uncontrolled angina pectoris , myocardial infarction, heart failure within 3 months 3) Uncontrolled diabetes 4) Severe complication (infection, bowel obstruction, or hemorrhage etc.) 5) Intestinal pneumonia or lung fibrosis 6) Severe diarrhea 7) Massive pleural, cardiac, or abdominal effusion 8) Regular use of fenitoin, warfarin or frucitocin 9) Symptomatic brain metastasis 10) History of severe drug allergic reaction 11) History of bone marrow plantation or self peripheral blood stimulated transportation 12) Pregnant women or women willing child-bearing 13) Inadequate condition diagnosed by primary physician

Related Information

• Primary Sponsor: Department of Medical Oncology, Kinki University School of Medicine
• Source(s) of Monetary Support: Department of Medical Oncology, Kinki University School of Medicine