Non-small cell lung cancer
Conditions
Interventions
nab-paclitaxel is administered at a dose of 100mg/m2 intravenously on day1,8,15. A treatment cycle is repeated every 28 days.
Sponsors
Osaka City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed diagnosis on non-small cell lung cancer. Non-small cell lung cancer with stage IIIB, stage IV, recurrent disease. 2)The patients who previously treated with the chemotherapy of 1 or 2 regimen including the platinum combination chemotherapy. Recurrence within 6 months or less from the adjuvant chemotherapy finished is considered a previous treatment. Patients with active EGFR mutations or ALK translocations need previously treated with EGFR-TKIs, Crizotinib, respectively. (but not count as 1 regimen) 3)Without treatment history of nab - paclitaxel or paclitaxel 4)Interval from previous chemotherapy EGFR-TKI, Crizotinib : more than 14 days Other chemotherapy: more than 28 days 5)Interval from previous palliative radiotherapy and surgery (for metastatic site) : more than 14 days after the last treatment 6)Interval from previous chest radiotherapy: more than 42 days after the last irradiation to lung 7)The presence of measureable lesions by RECIST 8)Age of 20 years or older 9)Performance Status (ECOG) 0 - 2 10)Adequate organ function Granulocyte count 1,500/mm3 or over Platelet count 100,000/mm3 or over Hb 9.0g/dL or over AST/ALT 2.5 x the Upper Limits of Normal (ULN) or under Total bilirubin 1.5mg/dL or under Serum creatinine 1.0 x the Upper Limits of Normal (ULN) or under SpO2 90 % or over 11)Life expectancy more than 3 months 12)Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1)Small cell carcinoma (in the whole or a part of the tumor) 2)Interstitial pneumonia or pulmonary fibrosis detectable on X ray 3)Uncontrolled pleural effusion, ascites, or pericardial effusion 4)Symptomatic brain metastasis 5)Active synchronous malignant neoplasm 6)Uncontrolled diabetes or hypertension 7)History of severe heart disease 8)Anamnesis of hypersensitivity to paclitaxel or albumin 9)Anamnesis of hypersensitivity to drugs 10)Patients with severe infection 11)Pregnancy or lactating patients 12)Patients who were judged inappropriate to entry this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Safety | — |
Countries
Japan
Contacts
Public ContactAsuka Tsuya
Osaka City General Hospital Department of clinical oncology
Outcome results
None listed