EGFR wild type, scale, non-small cell lung cancer
Conditions
Interventions
Case series:Docetaxel 60mg/m2, i.v. repeat three weeks a cycle, 4 - 6 courses
apatinib 250mg, p.o. qd, 28 cycles
Sponsors
Nanjing Military Region General Hospital
Eligibility
Sex/Gender
All
Age
38 Years to 81 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. The pathology diagnosed late (stage IIIB, IV) the scales, and non-small cell lung cancer, with a measurable lesion (tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher, scanning is not more than 5 mm, with a thick layer of measurable lesions not received radiotherapy, refrigeration, etc); 3. After EGFR mutation testing confirmed negatie for EGFR mutations (EGFR wild type); 4. Drug treatment should be continued at least contains a platinum based chemotherapy regimens, recurrent or failure, always had EGFR - TKI treatment patients can into the group; The definition of 'treatment failure': (1) in the process of treatment or disease progression after treatment at the end of the time, must have clear imaging or clinical evidence; (2) could not be intolerance events out of the standard treatment by CTCAE 4.0 standard, the intolerance of adverse events mean acuity level IV hematology toxicity or acuity levels III non hematologic toxicity or acuity II heart, liver, kidney and other major organs damage. 5. ECOG score: 0 and 1; 6. Survival is expected or greater in March; 7. The subjects treated with other damage has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more;Accept other cytotoxic drugs, bevacizumab (Avastin), radiotherapy, or surgery four weeks or more;EGFR TKI molecular target drugs or greater 2 weeks; 8. Major organs function is normal, that meet the following criteria: (1) the blood routine examination standards must be in accordance with (14 days without blood transfusion and adjuvant therapies, unused and other hematopoietic stimulating factor (g-csf) correct): HB 90 g/L or higher; the ANC acuity 1.5 x 10^9/L; PLT acuity 80 x 10^9/L; (2) and biochemical examination must be in accordance with the following criteria: TBIL 45 ml/min (Cockcroft - Gault formula); 9. Women of childbearing age must have reliable contraceptive measures or in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last for 8 weeks after experimental drug using appropriate methods of contraception.For men, must be agreed to at the end of the experiments and tests of giving drugs after 8 weeks using appropriate methods of contraception or has sterilization surgery; Subjects were willing to join in this study, and sign the informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinomas (including gland scale cancer);Small cell lung cancer (including small cell carcinoma and non-small cell lung cancer). 2. Cancer meningitis; Cancer patients with spinal cord compression, CT or MRI examination revealed brain imaging or screening or soft meningeal disease (21 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage); 3. The imaging (CT or MRI) shows that the tumor lesion vessels have 5 mm or less, or into the center of the large vessels tumor; 4. Imaging (CT or MRI) showed obvious lung empty or necrotic tumor; 5. Unable to control high blood pressure (systolic blood pressure or greater 140 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment); Level is above 6. With II myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); 7. According to NYHA standard, III to IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or is treated with thrombolysis and anticoagulation; 9. Application of anticoagulant or vitamin K antagonists such as warfarin, heparin, or the similar drug treatment of patients; Note: in the standardization of the prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose heparin (adult daily dose is 06000 ~ 12000 U) or low-dose aspirin (100 mg daily dosage or less). 10. 2 months prior to random obvious coughing up blood, or daily haemoptysis quantity up to half a teaspoon (2.5 ml) or above; 11. Random before 3 months there have been significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of defecate occult blood, or those with vasculitis, etc.; 12 months before 12. Random dynamic/enous thromboembolism events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 13. The known inherited or acquired bleeding and thrombosis tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, the splenic function, etc.); 14. Long-term not cure the wound or fracture; 15. Random received within 4 weeks before major surgery or severe traumatic injury, fractures or ulcer; 16. Significant factors affecting oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc.; 17. There have been a period of 6 months before random abdominal fistula, gastrointestinal perforation or abdominal abscess; 18. Routine urine p + + hint of urine protein, or confirm 24 hours urinary protein quantity acuity 1.0 g; 19. The clinical symptoms, need surgical treatment of serous cavity effusion (including pleural effusion, ascites, pericardial effusion); 20. Active hepatitis b patients with viral hepatitis b or hepatitis c; 21. Active infection need anti-microbial treatment (for example, to use antimicrobial, antiviral, antifungal drug treatment); 22. Has a history of psychiatric drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR;DCR;ORR;QoL; | — |
Countries
China
Contacts
Public ContactSong Yong
Nanjing Military Region General Hospital
Outcome results
None listed