Non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks. Treatment can be continued unless PD or toxicity that is
Sponsors
Dokkyo Medical University
Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Definitively diagnosed with non-small cell lung cancer by the specimens histologically or cytologically. 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV 3) Prior chemotherapy is 1 regimen, which is platinum-based combination regimen (exclude EGFR-TKI and ALK inhibitor) 4) Age of 20 to 79 years 5) Without active cancer other than NSCLC 6) At least one measurable lesion 7) With adequate organ function neutrophil count => 1,500/mm^3 platelet => 100,000/mm^3 hemoglobin => 9.0g/dL AST/ALT < 2.5 times less than ULN T.Bil <= 1.5mg/dL serum creatinine <= 1.5mg/dL ECG: without clinically problematic abnorbomalities Peripheral neuropathy <= Grade 1 8) Life expectancy of at least 3 months 9) ECOG performance status 0 or 1 10) With written informed consent
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis 2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 3) With active double cancer or multicentric cancer 4) Treated with radiotherapy within the past four weeks. 5) With a history of the treatment with taxane. 6) With clinically important complications. 7) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem 8) With pleural effusion or pericardial effusion accumulates which need drainage 9) With the history of hypersensivity for nab-paclitaxel, CBDCA 10) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe. 11) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Public ContactYoshiki Ishii
Dokkyo Medical University Pulmonary Medicine and Clinical Immunology
Outcome results
None listed