Non-small cell lung cancer
Conditions
Interventions
Induction phase amrubicin35mg/m2 days 1-3, plus erlotinib 100mg days 1- 21, 4 cycles Maintenance phase erlotinib 100mg, until progression
Sponsors
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)pathologically proven non-small cell lung cancer stage IIIB/IV 2)wildb type EGFR 3)history of no more than two previos chemotherapis(includeing platinum doublet one regimen) 4)no prior treatment with anthracycline including amrubicin anad EGFR-TKI 5)patients who can receive oral anticancer agents 6)hospitarization during the first four weeks of treatment 7)between 20 and 74 years old 8)performance status (ECOG)0-1 9)measurable lesions by RECIST 10)sufficient function of main organ and bone marrow 11)estimated survival of at least 3 months 12)interval from previous treatment, Chemotherapy:morethan 3 weeks Radiation:more than 12 weeks after the last irradiation to another organs 13)signed informed consent
Exclusion criteria
Exclusion criteria: 1)interstitial pneumonia or pulmonary fibrosis detectable on CT 2)3)smoking within 1 year 4)active severe infections 5)massive pleural effusion, ascites pericardial effusion 6)radiation of primary region or measurable region 5)history of sevirevere drug allergy 6)clinically important opthalmic disorders 7)brain metastasis associated with central nervous symptoms(patients were ineligible if the symptoms were controlled by steroids) 8)active concomitant cancers 9)history of concomitant cancers within 5 years 10)history of bone marrow transplant or peripheral stem cell transplantation 11)constant diarrhea 12)with intestinal paralysis or ileus 13)current or previous(within the last 1 year) of GI perfomation 14)uncontrollable ulcer in digestive tract 15)uncontrolled diabetes 16)current or history of severe heart disease 17)severe psychological disease 18)pregnant or lactating women or those who declined contraception 19)patients who were judged to be not suitable for trial by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, disease control rate, time to treatment failure, overall survival, safety | — |
Countries
Japan
Contacts
Public ContactSakiko Otani
Kitasato university School of Medicine Department of respiratory medicine
Outcome results
None listed