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.

NCT ID: NCT02283476

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-11-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar continuous intravenous infusion

Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin

Group Type: EXPERIMENTAL

Endostar continuous intravenous infusion

Intervention Type: DRUG

Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.

Gemcitabine

Intervention Type: DRUG

Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total

Cisplatin

Intervention Type: DRUG

Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total

Endostar routine intravenous infusion

Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin

Group Type: ACTIVE_COMPARATOR

Endostar routine intravenous infusion

Intervention Type: DRUG

Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total

Gemcitabine

Intervention Type: DRUG

Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total

Cisplatin

Intervention Type: DRUG

Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total

Interventions

Endostar continuous intravenous infusion

Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.

Intervention Type: DRUG

Endostar routine intravenous infusion

Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total

Intervention Type: DRUG

Gemcitabine

Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total

Intervention Type: DRUG

Cisplatin

Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Cancer Hospital

Tianjin, , China

Countries

China

Central Contacts

Zhao Yan, Doctor

Role: CONTACT

yanzhao@163.com

18622221369

Facility Contacts

Jinhuai Xue, Master

Role: primary

xuejh1210@sina.com

8613502065304

Other Identifiers

SIM-ED-1302

Identifier Type: -

Identifier Source: org_study_id