Clinical trial NCT02283476: 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.
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Cancer
Keywords: efficacy and safety
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.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.


Eligibility criteria: Inclusion Criteria:

1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
2. phase IIIB /IV based on IASLC 2009 TNM criteria.
3. at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
4. male or female, age≥18 or ≤75 years old
5. ECOG PS: 0 or 1
6. estimated time of survival: ≥ 3 months
7. suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
8. suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
9. suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
10. EKG normal
11. without no healing wound
12. no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment.
13. for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment.
14. no history of serious allergic to biologic agents, especially E.Coli products
15. the authorized ICF must be signed

Exclusion Criteria:

1. Woman in pregnancy and breast-feeding, or having productive ability without contraception.
2. Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
3. Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
4. 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.
5. Having the tendency of bleeding, such as FIB\<2G/L
6. Being receiving adjuvant chemotherapy.
7. On other conditions investigator considers, the subject is not fitful to participate the trial.

Primary outcomes:
measure: objective response rate based on Recist 1.1 edition
timeFrame: 3 months
measure: progress free survival
timeFrame: 18 months
Secondary outcomes:
measure: overall survival
timeFrame: 24 months
measure: Quality of life (QoL) Questionnaire
timeFrame: 24 months
Other outcomes:
measure: biological marker: CECs
timeFrame: 3 months
Locations:
city: TianJin
country: China
facility: Tianjin Cancer Hospital
Study officials:
References: