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
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
efficacy and safety
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endostar continuous intravenous infusion Type: Drug
Name: Endostar routine intravenous infusion Type: Drug
Name: Gemcitabine Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Tianjin Cancer Hospital
TianJin, China
Status: Not yet recruiting
Contact: Jinhuai Xue, Master - 8613502065304 - xuejh1210@sina.com
Start Date
November 2014
Completion Date
November 2017
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Source
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page