Phase I–II study of TS-1 and Carboplatin in advanced Non Small Lung Cancer
- Conditions
- non small cell lung cancer
- Registration Number
- JPRN-C000000054
- Lead Sponsor
- Department of Medical Oncology, Kinki University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 25
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decision of the recommended dose of TS1 and carboplatin
- Secondary Outcome Measures
Name Time Method Determination of dose limited toxicity and response and safety of the combination of TS1 and carboplatin