Advanced non-squamous non-small cell lung cancer
Conditions
Interventions
Patients were included in the run-in phase (four cycles of cisplatin, pemetrexed plus bevacizumab).After induction chemotherapy, patients who did not have progressive disease receive bevacizumab plus
Sponsors
Hamamatsu Univ. School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants must meet the following criterias 1: Pathologically proven Non-Sq NSCLC 2: Radiographically measurable lesion 3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4: Stage 3B/4 NSCLC or recurrence disease without prior adjuvant chemotherapy 5: Age more than 20 years and less than 75 years 6: Adequate organ function Neutrophil count: more than 1,500/uL Platelet count: more than 100,000/uL Hemoglobin: more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range Total bilirubin: less than 1.5mg/dL. PaO2: more than 60 torr Creatinine: less than 1.2mg/dL 7: Life expectancy of more than 12 weeks 8: Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 4: Uncontrolled massive pleural effusion or cardiac effusion 5: Superior vena cava syndrome 6: Uncontrolled brain metastases 7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months 8: Severe infection 9: Pregnancy or lactation 10: Active concomitant malignancy 11: History of severe allergic reactions to drugs 12: Evidence of bleeding diathesis or hemoptysis 13: Current or previous history of cerebrovascular disease 14: Current or previous history of GI perforation 15: With great vessel invasion 16: Exposure of the tumor to the central airway 17: Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day or Clopidogrel over 75mg/day) 18: Patients with arterial thrombosis or venous thrombosis 19: Severe and unstable medical comorbidities 20: Judgment to attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, disease control rate, overall survival, safety, QOL score(EQ-5D) | — |
Countries
Japan
Contacts
Public ContactSeiichiro Suzuki
Hamamatsu Univ. School of Medicine Department of Internal medicine, second division
Outcome results
None listed