Non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 on day 1,8,15 Cycles are repeated every three weeks.
Sponsors
Department of Respiratory Medicine , Kumamoto University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed diagnosis of NSCLC. 2) Non-small cell lung cancer with stage IIIB,stageIV 3) Age of 20 years or older 4) Performance Status (ECOG) 0-2 5) Tumor has the evaluable lesion. 6) Patient previously treated with platinum-based chemotherapy .and who including EGFR-TKI, ALK inhibitor or maintenance chemotherapy but excluding switch maintenance. *Recurrence within a year or less from the day adjuvant chemotherapy finished is considered a previous treatment. 7) Have adequate organ function within two week before study entry a.Granulocyte count 1,500/mm3 or over b.Platelet count 100,000/mm3 or over c.Hb 9.0 g/dl or over d.AST (GOT) 2.5 x the Upper Limits of Normal (ULN) or under e.ALT (GPT) 2.5 x the Upper Limits of Normal (ULN) or under f.Total bilirubin 1.5 mg/dL or under g.Serum creatinine 1.5 mg/dl or under h.PaO2 60torr or over or SpO2 90% or over 8) Written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Anamnesis of hypersensitivity to paclitaxel or albumin 2) Treatment history of taxanes (recurrence after more than one year from adjuvant chemotherapy including taxanes is permitted.) 3) Patient received chemotherapy within 4 weeks or EGFR-TKI within 2 weeks. 4) Patient received curative radiotherapy within 6 weeks or regional palliative radiotherapy within 2weeks. 5) Patient received operation within 4 weeks or surgical open within 2 weeks. 6) Symptomatic brain metastasis 7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 8) Active infectious disease in need of systemic administration of anti-bacterial drugs 9) Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on) 10) Patient needed to be administered with immunosuppressive drugs such as azathioprine , cyclophosphamide , methotrexate , or steroid 11) Active double cancer within 5 years of disease free interval (but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer ,by endoscopic mucosal resection , curative cutaneous cancer except for malignant melanoma ) 12) Peripheral neuropathy Grade2 or over 13) Pregnancy or lactating patients , or no intention to practice birth control. 14) Uncontrolled psychiatric disease 15) Physician judged improper to entry this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Countries
Japan
Contacts
Public ContactShinya Sakata
Kumamoto University School Department of Respiratory Medicine
Outcome results
None listed