Objective of the study is to investigate efficacy and safety of Erlotinib for previously treated non-small cell lung cancer patients.
Conditions
Interventions
Erlotinib single therapy
Sponsors
Tottori University, Faculty of Medicine,Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal 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 with one or two chemotherapy. 3) No prior treatment with epidermal growth factor tyrosine kinase inhibitor. 4) Patients who has at least one or more measurable lesion(s) by RECIST. 5) Performance status (ECOG) 0-2 6) Patients who can be hospitalized for at least two weeks after beginning of the treatment or under similar management. 7) Patients aged 20 years or older. 8) Sufficient function of main organ and bone marrow filled the following criteria: 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. AST and alt, x 2 of upper limit of normal (ULN) or less. Total bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. SpO2 90% or above. 9) Patients who are considered to survive for more than 3 months. 10) interval: (1) Chemotherapy, more than 4 weeks after the last chemotherapy. (2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3) Operation, more than 4 weeks after the last operation (including pleurodesis) 11) Patients providing 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(gefitinib,trastuzumab,lapatinib,cetuximab). 5) Impossible cases with oral administration. 6) Patients with active opthalmological disease. 7) Pregnancy or lactation. 8) Patients with symptomatic brain metastasis. 9) Patients with active concomitant malignancy. 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate,Progression Free Survival,Overall Survival,evaluation of safety | — |
Countries
Japan
Contacts
Public ContactShingo Matsumoto
Tottori University, Faculty of Medicine Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medi
Outcome results
None listed