chemotherapy-na&
Conditions
Interventions
CBDCA AUC=5(day1)+ Paclitaxel 200mg/m 2 (day1)+ Bevacizumab 15mg/kg (day1) q3weeks 2-6cycles Patients who get efficacy above SD without unacceptable toxity, then continuously are treated wit
Sponsors
Akita University Graduate School of Medicine
Akita University School of Medicine/ Department of Integrated Medicine, Department of Internal Medicine Division of Cardiovascular and Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous non-small-cell lung cancer 2)Stage IIIA-N2(multipule,bulky)/IIIB/IV without indication for curative radiation therapy 3)No prior systemic treatment advanced NSCLC 4)Performance Status(ECOG) 0-1 5)Patient who has at least one or more measurable lesion by RECIST 6)Patients aged 20 years or older 7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less. *Total bilirubin <=1.5mg/dL. *Serum creatinin, x 1.5 of ULN or less. *Electrocardiogram Nomal *SpO2 >=90% or SaPO2 >=65mmHg *Protein urea >= 1+ 8)Patients who are considered to survive for more than 3 months. 9)interval: (1) Radiation therapy *More than 2 weeks after the last irradiation to other organs. (2)Operation (including pleurodesis) *More than 4 weeks after the operation without Lobectomy (including exploratory surgery) *More than 2 weeks after the last operation (including pleurodesis) 10)Patients providing written informed consent
Exclusion criteria
Exclusion criteria: 1) Radiation therapy(expect chest) 2)Patients with untreated Brain metastases 3)Patients with current or previous history of hemoptysis (2.5mL or more) 4)Patients with uncontrolled hypertension 5)Patients with uncontrolled infection 6)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis 7)Patients with uncontrollable complications 8)Patients with massive pleural or pericardial effusion,or ascites 9)Patients with active concomitant malignancy 10)Patients with previous histories of drug allergy 11)Patients with uncontrollable gastrointestinal ulceration 12)Patients with current or previous (within one year) history of gastrointestinal perforation 13)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) 14)Pregnancy or lactation 15)Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Endothelial progenitor cells as biomarker Safety Maximum reduction rate of primary tumor size Resectability rate as induction therapy Progression Free survival Over all survival | — |
Countries
Japan
Contacts
Public ContactKazuhiro Imai
Akita University Graduate School of Medicine Department of Chest, Breast and Endocrinologic Surgery
Outcome results
None listed