Non-small cell Lung Cancer
Conditions
Interventions
Erlotinib 150mg daily
Sponsors
Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL Department of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven stage IIIb or IV non-small cell lung cancer. 2) Patients who have previously treated one platinum containing regimen (adjuvant chemotherapy counts one regimen). 3) Patients having EGFR mutation (exon 19 deletion or L858R) 4) Patient who has at least one or more measurable lesion by RECIST. 5) ECOG performance status (PS): 0-2 6) Patients who can be hospitalized for one or two weeks after beginning of the treatment or under management to apply to it. 7) Patients aged 20 years or older. 8) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment: Leukocyte counts, 3,000/mm3 or over -12,000/mm or less. Neutrophil counts, 1,500/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.0g/dL or over AST and ALT, x 2 of upper limit of normal (ULN) or less. Serum bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. BUN, 25mg/dL or less Adequate heart function by ECG SpO2 90% or above. 9) Patients who are considered to survive for more than 3 months. 9) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.) 10) (1)Chemotherapy: more than 4weeks after the last chemotherapy (2)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs (3)Operation: more than 4weeks after the last operation(including pleurodesis) 11) Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis 2)Patients with massive pleural or pericardial effusion ,or ascites 3)Patients with active severe infections 4)Cases with past history of administration of HER related agents 5)Impossible cases with oral administration 6)Patients with active opthalmological disease 7) Patients with active concomitant malignancy 8) Patients with symptomatic brain metastasis 9)Patients with double cancer 10)Patients with uncontrollabe diabetes mellitus 11)Patients with uncontrollable complications 12)Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Overall survival (OS) Toxicity profiles Quality of life | — |
Countries
Japan
Contacts
Public ContactMisasko Yamazaki
Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL Clinical Trial Centre
Outcome results
None listed