Non-small and non-squamous cell lung cancer
Conditions
Interventions
CBDCA and nab-PTX pulse BEV followed by nab-PTX pulse BEV
Sponsors
Department of Respiratory Medicine National Center for Global health and Medicine-Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I) Eligibility criteria for 1st registration 1) Histologically or cytologically proven non-squamous and non-small cell lung cancer 2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment 3) Naive treatment of cytotoxic chemotherapy and recurrence more than 6 months ago after completion of postoperable adjuvant chemotherapy. OK432 pleurodesis for malignant pleural effusion is acceptable for pretreatment. 4)Eastern Cooperative Oncology Group performance status of 0-1 5)Age > or = 20 years 6) Tumor has the evaluable lesion. 7) Adequate organ function, Adequate organ function within 2 weeks a) Leukocyte count > or = 3,000/mm3 b) Neutrophil count > or = 1,500/mm3 c) Platelet count > or = 100,000/mm3 d) Hemoglobin concentration > or = 9.0 g/dl e) Total bilirubin level < or = 1.5 mg/dl f) Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L g) Serum creatinine levels < or = 1.5 mg/dl h) Acceptable cardiac function i) Peripheral neuropathy < or = grade 1 9) Estimating Survival more than 3 months 10)Written informed consent II) Eligibility Criteria for 2nd registration 1) More than 2 cycles of induction chemotherapy 2) Response criteria of induction chemotherapy achieved more than and equal to SD. 3) Recover within 6 weeks after start of last cycle of induction therapy. 1.PS 0-1 2.Leukocyte count > or = 3,000/mm3 3.Neutrophil count > or = 1,500/mm3 4.Platelet count > or = 100,000/mm3 5.Hemoglobin concentration > or = 8.0 g/dl 6.Total bilirubin level < or = 1.5 mg/dl 7.Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L 8.Serum creatinine levels < or = 1.5 mg/dl 9.Peripheral neuropathy < or = grade 2 10.Hypertension < or = grade 2 11.proteinuria < or = grade 2 12.any bleeding < or = grade 1 13.thromboembolic event absence
Exclusion criteria
Exclusion criteria: 1) Patients with squamous cell lung cancer. 2) History of allergic reaction for agents of present treatment 3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction 4) Active concomitant malignancy except carcinoma in situ, intra-mucosal carcinoma or cancer with more than 5 year disease free 5) Active infection more than and equal to grade 2 6) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 7) Patients required for continuing more than and equal to 10 mg/day of steroid therapy 8) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment 9) History of thromboembolic events 10) Any history of cerebral, myocardial, and pulmonary infarction 11) Bleeding tendency, blood coagulation disorder 12) Other ineligible for bevacizumab 13) Pregnant status or lactation 14) Uncontrolled psychiatric disease 15) Other ineligible status judged by medical oncologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) from the beginning of maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (RR) by RECIST, Disease control rate (DCR), Overall survival (OS), Time to treatment failure (TTF), maintenance rate, PFS from the start of induction therapy, Adverse events, | — |
Countries
Japan
Contacts
Public ContactYuichiro Takeda
National Center for Global health and Medicine-Hospital Department of Respiratory Medicine
Outcome results
None listed