lung cancer
Conditions
Interventions
administration of nab-paclitaxel 100mg/m^2 weekly (day1, 8, 15
3 weeks for each cycle) until disease progression or unacceptable toxicities
Sponsors
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Definitively diagnosed with having previously treated advanced non-small cell lung cancer by the specimens histologically or cytologically. 2) Age of more than 18 years-old 3) PS (ECOG); 0-2 4) with the status of previously being treated with standard chemotherapy: previously treated with docetaxel for squamous cell carcinoma; previously treated with both docetaxel and pemetrexed for non-squamous cell carcinoma; or intraindication for docetaxel or pemetrexed 3) With adequate organ function of bone marrow reserve, liver, and kidney. (1) neutrophil count => 1,500/mm^3 (2) platelet => 100,000/mm^3 (3) AST/ALT < 2.5 times less than ULN (4) hemoglobin => 9.0g/dL (5) serum creatinine <= 1.5mg/dL (6) 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) Previously treated with paclitaxel 2) With uncontrolled brain metastasis 3) With clinically active infection 4) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 5) With uncontrolled pleural effusion 6) With active other organ cancer 7) With the history of severe drug allergy 8) With the history of hypersensivity for paclitaxel, albumin-containing agents 9) With uncontrolled digestive ulcer 10) 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 ContactYusuke Okuma
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital Department of Thoracic Oncology and Respiratory Medicine
Outcome results
None listed