A phase II study of nedaplatin plus irinotecan for stage III/IV and EGFR mutation negative non-small cell lung cancer with high-risk factors
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000003622
- Lead Sponsor
- Kanagawa Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1)applicable over 2 risk factors above 2)ECOG Perfomance Status; 3 or 4 3)white blood cell count; less than 3,000/mm3 4)absolute neutrophil count; less than 1,500/mm3 5)hemoglobin; less than 9.0 g/dL 6)platelet count; less than 75,000/mm3 7)serum total bilirubin; 2.0 mg/dL or over 8)AST/ALT; 100 IU/L or over 9)serum creatinine; 1.5 mg/dL or over 10)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case) 11)evident pericardial effusion 12)serious complications below I)uncontrollable angina pectoris, myocardial infarction within 6 months or heart failure II)serious heart dosease III)uncontrollable diabetes or hypertension IV)infection 13)applicable for contraindication of nedaplatin I)serious myelosuppression II)serious renal failure 14)applicable for contraindication of irinotecan hydrochloride I)existing diarrhea (watery diarrhea) II)existing bowel paralysis or bowel obstructuction III)existing fresh bleeding of GI tract IV)existing jaundice V)existing myelosuppression 15)pulmonary fibrosis or interstitial pneumonitis evident on chest X ray 16)now pregnant or lactation, or possible pregnancy or refusal of contraception 17)difficult to perform or continue of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method