advanced or recurrent non-small-cell lung cancer
Conditions
Interventions
AdministrationofTheracurmin and erlotinib for 8 weeks. Dosage of erlotinib 150mg per day,Theracurmin, 3 cohorts, 180mg per day, 240mg per day, and 360mg per day.
Sponsors
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histological diagnosis of lung cancer 2)informed of lung cancer 3)compliant with oral medication 4)failure of standard treatments or first line erlotinib 5)PS 0-2 6)age over 20 7)approximately four weeks or more must pass from the prior treatment 8)Patients expected of 3 months or more survival 9)lesion that can be evaluated by RECIST 10) Adequate organ function AST and ALT <=4 times the standard values Total bilirubin <2.0mg/dL Creatinine <2.0mg/dL ECG normal SpO2>90% 11)Written consent
Exclusion criteria
Exclusion criteria: 1)idiopathic pulmonary fibrosis, interstitial pneumonia, radiation pneumonitis, drug related pneumonitis 2)plueral, peritoneal, or pericardial effusion requiring drainage 3)active infection 4)unable to take oral medication 5)symptomatic eye disorders 6)pregnant or lactating 7)symptomatic brain metastasis 8)other malignancies 9)uncontrolled diabetes 10) active complications 11)patients whom physicians judged to be unsuitable for enrollment for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Countries
Japan
Outcome results
None listed