Non-small cell lung cancer
Conditions
Interventions
Erlotinib
Sponsors
Showa University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Unresectable advanced or recurrent disease 3) Age is over 20 years. 4) Performance status (ECOG) is 0 to 2 5) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy Absolute neutrophil count>1,500/mm3 Platelet count>100,000/mm3 Hemoglobin>8.0g/dL AST and ALT<2.5 times the upper limit of normal(ULN) Total bilirubin<2.0mg/dL 6) Signed, written informed concent is obtained
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia, pulmonary fibrosis 2) Severe active infection 3) Serological positive for HBs-antigen or HCV-antibody 4) Previous therapy with pazopanib 5) Unstable angina or myocardial infarction within 3 months 6) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease) 7) Active synchronous cancer 8) Severe psychiatric disorder 9) Pregnant or lactating women, or men and women without wanting pregnancy 10) Severe hypersensitivity to medicine 11) Taking medicines affecting CYP3A4 within one week before starting gefitinib therapy (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, ketokonazole, macrolide) 12) Taking proton pump inhibitor or H2 blocker within one week before starting gefitinib therapy 13) Patients who were judged inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To elucidate the pharmacokinetic factors relating erlotinib-induced toxicity | — |
Countries
Japan
Contacts
Public ContactHiroo Ishida
Showa University School of Medicine Division of Medical Oncology, Department of Medicine
Outcome results
None listed