Non-small Cell Lung Cancer
Conditions
Keywords
Endostar, advanced Non-small cell lung cancer, Continued Pumping into vein, Gemcitabine, Carboplatin
Brief summary
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
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-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.
Interventions
DRUGEndostar -Continued Pumping into+GP
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2\*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.
DRUGEndostar -injecting into +GP
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg 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 2-4cycles
Sponsors
Beijing Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically diagnosed NSCLC; 2. primary treatment,inoperable stage IIIB/IV NSCLC; 3. Age of 18-75years; 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 |
| Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability | two years |
Countries
China
Contacts
Primary ContactLiyan Xu, MD
Outcome results
None listed