Non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel is administered 100 mg/m2 on day 1, 8, 15 every 3 weeks, Carboplatin is administered AUC5 on day 1 every 3weeks.
Sponsors
Kanto respiratory disease study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed Clinical Stage IIIB, IV or postoperative recurrence 2) Age of more than 75 years-old 3) Not with active other organ cancer 4) With one or more measurable lesion 5) No prior chemotherapy Adjuvant chemotherapy finished before 4 weeks or more in case of UFT, 12 months or more in case of other chemotherapy from enrollment is permitted. 6) With adequate organ function of bone marrow reserve, liver, and kidney. Sufficient major organ function as bellow Neutrophil count => 1,500 /mm3 Platelet count => 100,000 /mm3 Hemoglobin => 9.0 g/dL AST(GOT)/ALT(GPT) <= 2.5 times less than ULN total bilirubin <= 1.5 mg/dL Serum creatinine <= 1.5 mg/dL ECG: without clinically problematic abnorbomalities Peripheral neuropathy <= Grade 1 7) Life expectancy of at least 3 months 8) ECOG Performance status of 0-1 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with Symptomatic brain metastasis 2) Patients have only non-measurable lesion 3) Patients with radiotherapy for cancer within 4 weeks 4) Patients with interstitial pneumonia 5) Patients with Serious complications (renal dysfunction, liver dysfunction, cardiac diseases, uncontrolled hypertension or diabetes) 6) Patients with other Serious complications 7) Judged ineligible based on physicians' decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, Frequent of adverse event, Progression free survival, Overall Survival, Rate of secondary treatment | — |
Countries
Japan
Contacts
Public ContactNobuyuki Koyama
Tokyo Medical University Hachioji Medical Center Department of Clinical Oncology
Outcome results
None listed