Refractory 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 3 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) Patients with histlogically or cytologically confirmed small cell lung cancer 2) Patients are difficult to treat with adapted drugs to the small cell lung cancer. (patients completed or not acceptable the standard chemotherapy) 3) 20<=, <75 years old 4) Without active cancer other than NSCLC 5) At least one measurable lesion 6) 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 abnormalities Peripheral neuropathy <= Grade 1 7) Life expectancy of at least 3 months 8) ECOG performance status 0 or 2 9) 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 clinically important complications. 6) With pleural effusion or pericardial effusion accumulates which need drainage 7) With the history of hypersensitivity for nab-paclitaxel, CBDCA 8) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe. 9) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR), Progression free survival (PFS), Overall survival (OS), and Safety | — |
Countries
Japan
Contacts
Public ContactRyo Arai
Dokkyo Medical University Department of Pulmonary Medicine and Clinical Immunology
Outcome results
None listed