Non-small cell lung cancer
Conditions
Interventions
Bevacizumab plus Pemetrexed administrated on day 1 every 3 weeks
Sponsors
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically proven non-squamous non-small cell lung cancer. 2. Patients with StageIIIB/IV or recurrence non-small cell lung cancer and were not a candidate for curative radiotherapy. 3. Patients previously treated with chemotherapy (except EGFR-TKI for first line therapy and UFT for postoperative adjuvant chemotherapy). 4. Performance Status (ECOG) 0-1 5. Patients who have at least one or more measurable lesion by RECIST(Version1.1). 6. Patients aged 70 years or older. 7. Ineligible for standard cisplatin(bolus infusion)-containing combination chemotherapy. 8. Sufficient function of main organ and bone marrow filled the following criteria. Leukocyte counts >= 4,000/mm3 Neutrophil counts >= 2,000/mm3 Platelets >= 100,000/mm3 Hemoglobin concentration >= 9.5 g/dL AST and ALT, x 2.5 of upper limit of normal (ULN) or less Total bilirubin, 1.5mg/dL or less Serum creatinin, 1.2mg/dL or less SpO2 93% or above proteinuria, 1+ or less 9. interval (1) radiation therapy more than 2 weeks after the last radiation therapy for nonthoracic region (2) operation. More than 8 weeks after the last operation with pulmonary resection. More than 4 weeks after the last operation without pulmonary resection. More than 2 weeks after the last pleurodesis or thoracic cavity drainage. 10. Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastasis. 2. Patients with current or previous hemoptysis. 3. Patients treated with radiation therapy for thoracic region. 4. Patients with active severe infections. 5. Patients who have fever of over 38 degrees. 6. Patients with serious complication (cardiac affection, interstitial pneumonia, uncontrollable hypertension, or uncontrollable diabetes mellitus, etc.) 7. Patients with massive ascites, pleural or pericardial effusion. 8. Patients with concomitant malignancy. 9. Patients with history of drug allergies. 10. Patients with uncontrollable gastrointestinal ulceration. 11. Patients with current or previous (within one year) history of gastrointestinal perforation. 12. Patients treated with anticoagulation therapy. 13. Inappropriate patients for this study judged by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Progression-free survival, Overall survival, Completion proportion of 3 cycles | — |
Countries
Japan
Contacts
Public ContactNaoyuki Nogami, Toshiyuki Kozuki
National Hospital Organization Shikoku Cancer Center Department of thoracic oncology
Outcome results
None listed