non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel at the dose of 100mg/m2 (day 1, 8, 15) is administered every 4 weeks. Treatment can be continued unless PD or toxicity that is not tolerable is found.
Sponsors
Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital
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 or 2 regimen. Regimen count is defined as follows a. Exclude EGFR-TKI and ALK inhibitor b. Exclude continuation maintenance, include switch maintenance c. Include adjuvant chemotherapy 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 a. neutrophil count => 1,500/mm^3 b. platelet => 100,000/mm^3 c. hemoglobin => 9.0g/dL d. AST/ALT < 2.5 times less than ULN e. T.Bil <= 1.5mg/dL f. serum creatinine <= 1.5mg/dL g. ECG: without clinically problematic abnorbomalities h. 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) The peripheral sense neuropathy is Grade2 or more by CTCAE at registration. 5) Treated with radiotherapy within the past four weeks. 6) With a history of the treatment with Paclitaxel. 7) With clinically important complications. 8) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem 9) With pleural effusion or pericardial effusion accumulates which need drainage 10) With the history of hypersensivity for paclitaxel or albumin 11) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe. 12) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, toxicities, progression-free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactYoshio Tomizawa
Incorporated Administrative Agency National Hospital Organization Nishigunma National Hospital Department of Respiratory Medicine
Outcome results
None listed