The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.

Study Overview
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Brief Summary
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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.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.

Official Title
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The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Endostar continuous intravenous infusion
* Drug: Endostar routine intravenous infusion
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination. phase IIIB /IV based on IASLC 2009 TNM criteria. at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT ) male or female, age≥18 or ≤75 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 no healing wound no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment. for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostar continuous intravenous infusion<br>Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin | Drug: Endostar continuous intravenous infusion<br>* Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.<br>Drug: Gemcitabine<br>* Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total<br>Drug: Cisplatin<br>* Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total<br>|
| Active Comparator: Endostar routine intravenous infusion<br>Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin | Drug: Endostar routine intravenous infusion<br>* Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total<br>Drug: Gemcitabine<br>* Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total<br>Drug: Cisplatin<br>* Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate based on Recist 1.1 edition |  | 3 months | 
| progress free survival |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 24 months | 
| Quality of life (QoL) Questionnaire |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy and safety