Non-Small Cell Lung Cancer
Conditions
Interventions
Erlotinib : 150mg/day p.o. Predonisolone : 5mg/every other day p.o. on days 1-28 Minocycline : 100mg/day p.o. on days 1-28
Sponsors
Toho University Medical Cencer Sakura Hospital, Department of Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with all of the following conditions; 1) Historogically or cytologically proven stage.IIIb or IV non-small cell lung cancer 2) Recurrent non-small cell lung cancer already treated with 1 or 2 regimen, excluding post-operative adjuvant chemotherapy 3) Age equal or older than 20-y at enrollment 4) No prior treatment with EGFR-TKIs 5) Able to be treated with PO medication 6) PS of 0, 1 or 2 7) Able to be intensely monitored at least for 2 weeks 8) Adequate organ functions, evaluated within 2 weeks before enrollment, as; a) Netrophile >= 1,500/mm3 b) Hb >= 8.0 g/dL c) Plt >= 75,000/mm3 d) AST/ALT <= 100 IU/L e) T. Bil <= 1.5 g/dL f) SpO2 >= 90% 9) Life expectancy of more than 3 months 10) Interval from previous treatment, of following, at enrollment; a) Equal or more than 4 weeks after completion of thoracic irradiation b) Equal or more than 1 week after completion of irradiation except for thoracic irradiation 11) Witten informed consent from the patient
Exclusion criteria
Exclusion criteria: Patients with at least one of the following conditions are ineligible 1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage 2) Patients unable to be treated with PO drugs 3) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis 4) Pregnancy, breast feeding and suspected pregnancy 5) Active synchronous malignancies 6) Other clinically significant complications 7) History of hypersensitivity for drugs used for this study and tetracyclines antibiotics Other conditions inadequate for this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin toxicity (Grade2-) rate at week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the onset of skin toxicity (any Grade) Skin toxicity appearance rate of each Grade Antitumor effect Time to Treatment Failure Overall Survival Safety Quality of life Time to recovery from skin toxicity | — |
Countries
Japan
Contacts
Public ContactTatsuo Kawashima
Toho University Medical Cencer Sakura Hospital Department of Internal Medicine
Outcome results
None listed