Non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4weeks.
Sponsors
National Hospital Organization Asahikawa Medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 3) Disease progression or recurrence after the last treatment for non-small cell lung cancer is confirmed by radiological image. The number of previous regimens must be 2 or less *Previous treatments should include at least one platinum-based regimen *Adjuvant chemotherapy is counted as one regimen if the disease recurred within a year after the completion of postoperative adjuvant chemotherapy, or within a year after surgery in patients given preoperative adjuvant chemotherapy * The following treatments are not counted as one regimen 1.Picibanil use for pleurosclerosis 2.Continuation maintenance therapy 3.EGFR-TKI and ALK inhibitor use for each driver mutation 4) At least one measurable lesion 5) Age of 20 years or older 6) ECOG Performance status of 0-2 7) Sufficient major organ function as bellow *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *AST <= 100 IU/L *ALT <= 100 IU/L *total bilirubin <= 1.5 mg/dL *PaO2 >= 60 Torr or more (or SpO2 >= 94% or more) 8) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Previous treatment with paclitaxel (2) Patients who remain influence of prior treatment which disturb protocol treatment (3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Active infection requiring administration of systemic treatment with antibiotics. e.g. Body temperature rose higher than 38 degree centigrade 6) Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade 3 or higher angina 7) Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids 8) Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer 9) Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men) 10) Psychiatric disorder or symptom that makes participation of the patient difficult 11) Continuous administration of a steroid 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 |
|---|---|
| Overall Survival Progression Free Survival Time to Treatment Failure Disease Control Rate Adverse Events | — |
Countries
Japan
Contacts
Public ContactYuka Fujita
National Hospital Organization Asahikawa Medical center Respiratory Medicine
Outcome results
None listed