Squamous cell lung cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 on days 1, 8, 15 + Carboplatin AUC 6 on day 1 every 4 weeks.
Sponsors
OSAKA-LCSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed squamous cell lung cancer. 2) Clinical Stage III which curative radiotherapy is not indicated, IV or postoperative recurrence 3) MNA-SF score >= 8 4) No prior chemotherapy *Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted. 5) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.) 6) At least one measurable lesion 7) Age of 70 years or older 8) ECOG Performance status of 0-1 9) Sufficient major organ function as bellow *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *total bilirubin <= 1.5 mg/dL *AST/ALT <= ULN*2.5 *Serum creatinine <= 1.5 mg/dL *PaO2 >= 60 Torr or more (or SpO2 >= 95% or more) 10) Life expectancy of at least 3 months 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Previous treatment with paclitaxel as adjuvant chemotherapy 2) Active double cancer 3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Grade 2 or higher peripheral neuropathy 6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 7) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes) 8) History of Severe drug allergies. 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 10) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival, Disease control rate, SPARC expression and safety. | — |
Countries
Japan
Contacts
Public ContactTakayuki Shiroyama
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Department of Thoracic Malignancy
Outcome results
None listed