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.

Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02283476
• Other study ID #: SIM-ED-1302
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 3, 2014
• Last updated: November 5, 2014
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: October 2014
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Zhao Yan, Doctor
• Phone: 18622221369
• Email: yanzhao[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 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.
• 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
• Gemcitabine
Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total
• Cisplatin
Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital	TianJin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	biological marker: CECs		3 months	No
Primary	objective response rate based on Recist 1.1 edition		3 months	No
Primary	progress free survival		18 months	No
Secondary	overall survival		24 months	No
Secondary	Quality of life (QoL) Questionnaire		24 months	Yes