non-small cell lung cancer
Conditions
Interventions
carboplatin at the dose of area under curve 5 (day 1) and nab-paclitaxel at the dose of 100mg/m^2 (day 1, 8, 16) every 3 weeks, upto 6 cycles
Sponsors
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically. 2) Age of more than 70 years-old 3) With adequate organ function of bone marrow reserve, liver, and kidney. (1) PS 0-1 (2) neutrophil count => 1,500/mm^3 (3) platelet => 100,000/mm^3 (4) hemoglobin => 9.0g/dL (5) AST/ALT < 2.5 times less than ULN (6) T.Bil <= 1.5mg/dL (7) serum creatinine <= 1.5mg/dL (8) ECG: without clinically problematic abnorbomalities (9) Peripheral neuropathy <= Grade 1 (10) SpO2 (room air) more than 92% 4) With the status of below previous treatment at the time of beginning of chemotherapy. (1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation (2) Surgical procedure, including pleurodesis or pleural drainage * more than 8 weeks with lobectomy * more than 4 weeks without lobectomy, including exploratory thoracotomy * more than 2 weeks after completing procedure (pleurodesis or pleural drainage) 5) With expected prognosis more than 12 weeks 6) With written informed consent
Exclusion criteria
Exclusion criteria: 1) The age of less than 70 years-old 2) Previously treated with chemotherapy 3) With uncontrolled brain metastasis 4) With clinically active infection 5) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) With uncontrolled pleural effusion 7) With active other organ cancer 8) With the history of severe drug allergy 9) With the history of hypersensivity for paclitaxel, albumin-containing agents 10) With the history of hypersensitivity for platinum agents 11) With uncontrolled digestive ulcer 12) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, toxicities, number of cycles | — |
Countries
Japan
Contacts
Public ContactOkuma, Yusuke
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital Department of Thoracic Oncology and Respiratory Medicine
Outcome results
None listed