Lung Cancer
Conditions
Brief summary
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.
Interventions
DRUGEndostar
continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
DRUGDocetaxel
docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle
DRUGCarboplatin
carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed
DRUGPemetrexed
pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination; Phase IIIB/IV based on TNM criteria (8th); At least one measurable tumor based on RECIST 1.1; Without the known active mutation of EGFR/ALK/ROS1/RET; Male or female, age≥18 or ≤70 years old; ECOG PS: 0 or 1; Estimated time of survival: ≥ 3 months; Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL; Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN; Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min; EKG normal; Without healing wound; No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment; For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment; No history of serious allergic to biologic agents, especially E.Coli products; The authorized ICF must be signed.
Exclusion criteria
Woman in pregnancy and breast-feeding, or having productive ability without contraception; Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound; Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension; Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms; Having the tendency of bleeding, such as FIB≤2G/L; Being receiving adjuvant chemotherapy; On other conditions investigator considers, the subject is not fitful to participate the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 8 weeks | objective response rate based on Recist 1.1 edition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 8 weeks | progress free survival |
Countries
China
Outcome results
None listed