Non-small cell lung cancer
Conditions
Interventions
Docetaxel
Docetaxel plus Bevacizumab
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with stage 3b/4 or recurrent non-squamous NSCLC who have progressed on one prior treatment with a platinum-based chemotherapy plus bevacizumab * A patient who has received pre- or postoperative chemotherapy is eligible if the last administration of the prior adjuvant regimen occurred at least 12 months prior to platinum-based chemotherapy plus bevacizumab. * A patient with history of treatment with EGFR-TKI (gefitinib or erlotinib) priot platinum-based chemotherapy plus bevacizumab is eligible if the patient had an EGFR mutation 2) Cytologically or histologically documented non-squamous cell carcinoma of the lung 3) More than 21 days since prior chemotherapy * A patient who has received platinum plus gemcitabine with bevacizumab is eligible if more than 21 days have passed since the last administration of platinum and bevacizumab, and more than 14 days of gemcitabine. * A patient who has received platinum plus S-1 with bevacizumab is eligible if more than 21 days have passed since the last administration of platinum and bevacizumab, and more than 7 days of S-1. 4) Life expectancy of at least 3 months 5) Age eligible for study: 20 years and above 6) ECOG performance status of 0 to 2 7) Have measurable lesion in a previously non-irradiated area according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 8) Have adequate organ function 9) Provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior treatment with docetaxel 2) Have central nervous system metastases (A patient who has previously treated brain metastases, without evidence of progression or hemorrhage at baseline is eligible) 3) Currently have or have a history of hemoptysis (>= one-half teaspoon of bright red blood per event) 4) Clinically significant drug allergy 5) Have a evidence of thrombosis 6) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide 7) Have a history of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; gastrointestinal perforation, gastroparesis, or obstruction 8) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management) Regarding the patient who have or have had pleural effusion; a) A patients who developed recurrent effusion within two weeks after drainage tube removal is ineligible b) A patient who received intrapleural chemotherapy (excluding BRM such as OK432) for pleurodesis is ineligible 9) Patients with or with anticipation of invasive procedures as defined below: a) Major surgery within four weeks of registration b) Palliative radiotherapy within two weeks of registration c) Minor surgical procedures, core biopsy or traumatic injury, within two weeks of registration d) Transfusion of any blood products within two weeks of registration 10) Have another active malignancy 11) Interstitial pneumonia or pulmonary fibrosis documented obviously in chest X ray 12) Mental disease or psychotic manifestation 13) Pregnant or beeast-feeding woman or patient who doesn't agree to contraception 14) Not suitable for participating in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Overall Survival, Safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed