Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, Endostar, Continued Pumping into, Gemcitabine, Carboplatin
Brief summary
The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.
Detailed description
Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection. Methods: In this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),
Interventions
DRUGGemcitabine,Carboplatin,Endostar
Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2\*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.
DRUGGemcitabine(G) Carboplatin(C) Endostar
Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles
DRUGGemcitabine(G) Carboplatin(C)
Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically diagnosed NSCLC; 2. primary treatment,inoperable stage III/IV NSCLC; 3. Age of 18-70years; Gender Not Required; 4. Adequate hematologic, renal, and hepatic function ,Specific index as follows: liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\^9/l, ANC≥2.0×10\^9/l platelet count ≥100×10\^9/l, Hb≥100 g/l; 5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy; 6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI); 7. No history of serious drug allergy; 8. Informed consent should be obtained before treatment.
Exclusion criteria
1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications; 2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,); 3. Serious complications and investigator consider it is unsuited enrolling; 4. Pregnant or lactating women; 5. Allergic to research drug; 6. participating in other experimental trials and receive the treatment in four weeks; 7. The position that is for observing curative effect have a radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | two years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | two years |
| Clinical benefit rate (CBR) | two years |
| The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood. | two years |
| adverse reaction | two years |
| Time to progression(TTP) | two years |
Countries
China
Contacts
Primary ContactJianhua Chen, master
Outcome results
None listed