Non-small cell lung cancer
Conditions
Interventions
Nab-paclitaxel 100 mg/m2(Level 1) is administered intravenously over 30 minutes on days 1 and 15, repeated every 4weeks. Treatment dose level are level 0 (75mg/m2), level 2(125mg/m2), level 3 (150mg/m
Sponsors
North Japan Lung Cancer Study Group (NJLCG)
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) Between two and four regimens containing a platinum based chemotherapy are pretreated -Adjuvant chemotherapy is counted as one regimen if the disease recurred within 1 year after the compretion of postoperative adjuvant chemotherapy, or within 1 year after surgery in patients given preoperative adjuvant chemotherapy. -EGFR-TKI and ALK inhibitor use for each driver mutation is counted as one regimen. -Picibanil use for plural effusion is permitted. -Continuation maintenance therapy is permitted 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 *total bilirubin <= 1.5 mg/dL *AST <= 100 IU/L *ALT <= 100 IU/L *Serum creatinine <= 1.5 mg/dL *PaO2 >= 60 Torr (or SpO2 >= 93% ) 8) Life expectancy of at least 3 months 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Previous treatment with paclitaxel 2) Grade 2 or higher peripheral neuropathy 3) Active double cancer 4) Symptomatic brain metastases 5) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 6) Active infectious disease 7) Severe concurrent disease (intestinal paralysis, intestinal obstraction, poorly controlled diabetes, heart failure, renal failure, hepatic failure, active gastrointestinal ulceration, cardiac infarction within 6 months before enrollment, and grade 3 or higher angina so on) 8) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis. 9) Patient with autoimmune disease requiring immunosuppressive drugs 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Uncontrolled psychiatric disease 12) Patient are treated with steroid continuously 13) History of severe drug allergies. 14) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the maximum tolerated dose and recommended dose (Phase I) Response Rate (Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Progression-free Survival Adverse Events Disease Control Rate | — |
Countries
Japan
Contacts
Public ContactEisaku Miyauchi
Tohoku University Hospital Department of Respiratory Medicine
Outcome results
None listed