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.

NCT02283476 | Unknown Phase 3

• 1 other identifier: SIM-ED-1302
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

efficacy and safety

Outcome Measures

Primary Outcomes (2)

• objective response rate based on Recist 1.1 edition

  3 months

• progress free survival

  18 months

Secondary Outcomes (2)

• overall survival

  24 months

• Quality of life (QoL) Questionnaire

  24 months

Other Outcomes (1)

• biological marker: CECs

  3 months

Study Arms (2)

Endostar continuous intravenous infusion

EXPERIMENTAL

Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin

Drug: Endostar continuous intravenous infusion; Drug: Gemcitabine; Drug: Cisplatin

Endostar routine intravenous infusion

ACTIVE COMPARATOR

Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin

Drug: Endostar routine intravenous infusion; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Endostar continuous intravenous infusion DRUG

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

Endostar continuous intravenous infusion

Endostar routine intravenous infusion DRUG

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

Endostar routine intravenous infusion

Gemcitabine DRUG

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

Endostar continuous intravenous infusion; Endostar routine intravenous infusion

Cisplatin DRUG

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

Endostar continuous intravenous infusion; Endostar routine intravenous infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Zhao Yan, Doctor

CONTACT

18622221369; yanzhao@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2014

Record last verified: 2014-10

Locations

CN (1)