Non-small cell lung cancer
Conditions
Interventions
Erlotinib and Pemetrexed combinationtherapy
Sponsors
Osaka Univ.Hospital Respiratory Medicine
Osaka Police Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Stage IIIB/IV non-small cell lung cancer proven by histology and/or cytology 2)Non-Sqamous cell carcinoma 3)Patients who have previously treated with one chemotherapy. 4)Patients aged 20 years or older. 5)No prior treatment with TKI or Mab which affect to HER family. 6)No prior treatment with pemetrexed. 7)Patients who has at least one or more measurable lesion(s) by RECIST. 8)Performance status (ECOG) 0-2 9)Patients who can be hospitalized for at least one to two weeks after beginning of the treatment or under similar management. 10) Adequate organ functions, evaluated within 2 weeks before enrollment, as; a) WBC >= 3,000/mm3 b) Netrophile >= 1,500/mm3 c) Plt >= 100,000/mm3 d) Hb >= 9.0 g/dL e) AST/ALT, x 2 of upper limit of normal or less. f) T. Bil <= 1.5 g/dL g) Serum creatinine, x 1.5 of upper limit of normal or less. h) SpO2 >= 90% as room air 11)Patients are excepted to live over 3 months. 12)Interval from previous treatment, of following, at enrollment; (1)Equal or more than 3 weeks after completion of previous chemotherapy (2)Equal or more than 4 weeks after completion of thoracic irradiation. / Equal or more than 1 week after completion of irradiation except for thoracic irradiation (3)Equal or more than 2 weeks after surgical intervention.
Exclusion criteria
Exclusion criteria: 1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage 2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 3) Patients with infection requiring iv administration of antibiotics and/or antifungal agents 4) Patients unable to be treated with PO drugs 5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis 6) Pregnancy, breast feeding and suspected pregnancy 7) Severe bone marrow suppression 8) Symptomatic brain metastasis 9) Active synchronous malignancies 10) Severe renal function disorder (creatinin clearlance less than 45mL/min) 11) Uncontrolled diabetes mellitus 12) Other clinically significant complications 13) Other conditions inadequate for this research
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 ContactTakashi Kijima
Osaka Univ.Hospital Respiratory Medicine
Outcome results
None listed