non-small cell lung cancer
Conditions
Interventions
Bevacizumab Platinum-Doublet Chemotherapy
Sponsors
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
National Hospital Organization Kinki-Chuo Chest Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer (2)StageIV or recurrent non-small cell lung cancer without any chemotherapy (3)Age20=< (4)With one or more measurable disease based on RECIST (5)ECOG performance status of 0 to 2 (6)Adequate organ function, evaluated within 14 days before enrollment as WBC>=3,000/mm3 Neu>=1,500/mm3 Plt>=10.0x10000/mm3 hemoglobin >=9.0g/dL T-bil=<1.5mg/dL AST,ALT=<2.0xULN Cr>=1.5xULN SpO2>=90% Proteinuria<1+ (7) Interval -Immune therapy, Endocrine therapy >3wks -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage >1wks -biopsy with dissection, indwelling port >2wks -Aspiration biopsy cytology >1wks (8) Expected to live over 3 months after administration days. (9) Written informed consent from the patients.
Exclusion criteria
Exclusion criteria: (1)Symptomatic brain metastasis (2)>=3cm Untreated brain metastasis (3)Have another active malignancy (4) Current or previous history of hemoptysis (5) Evidence of tumor invading large vessel on imaging (6) Have received radiation therapy to lesions of lung (7) Currently have or have a history of a Ascites ,Pleural effusion or pericardial effusion which requires treatment (8) Symptomatic Brain infarction within 1 year (9) Problematic infection (10) Patients receiving (oral or intravenous) administration of continuous systemic steroids. (11) Sever complications (12) Scheduled operation (13)Active radiation pneumonitis or esophagitis (14) Patients with a history of severe hypersensitivity to drugs used in this trial. (15) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (16) Psychotic disease judged should not to participate the trial (17) Decision of ineligibility by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Overall survival, Response Rate, Response Rate for intracranial metastases | — |
Countries
Japan
Contacts
Public ContactMotohiro Tamiya/Takayuki Shiroyama
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases Department of Thoracic Malignancy
Outcome results
None listed