Non-small cell lung cancer
Conditions
Interventions
Nedaplatin 50 mg/m2(days 1, 8)+Irinotecan hydrochloride 50 mg/m2(days 1, 8) 4-5 weeks interval, total 1-4 courses
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed non-small cell lung cancer 2)unresectable, stage III or IV disease and radical radiotherapy unable 3)possess measurable lesion 4)EGFR mutation negative (wild type) 5)20 years old or over 6)naive to chemotherapy or radiotherapy, but recurrence after surgery case is eligible 7)written informed consent and applicable to 1 or 2 risk factors below 1)ECOG Perfomance status 2 2)70 years old or over 3)white blood cell count; 3,000/mm3 or over, or less than 4,000/mm3 4)absolute neutrophil count; 1,500/mm3 or over, or less than 2,000/mm3 5)hemoglobin; 9.0 g/dL or over, or less than 10.0 g/dL 6)platelet count; 75,000/mm3 or over, or less than 100,000/mm3 7)serum total bilirubin; over within normal limits but less than 1.5 mg/dL 8)AST/ALT; over within normal limits but less than 100 IU/L 9)serum creatinine; over within normal limits but less than 1.5 mg/dL 10)symptomatic brain or osseous metastasis
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events, progression free survival and over all survival | — |
Countries
Japan
Contacts
Public ContactTetsuro Kondo
Kanagawa Cancer Center Department of Thoracic Oncology
Outcome results
None listed