Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

Lung Cancer Clinical Trial

Official title:

The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706703
• Other study ID #: ENDOSTAR
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2018
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;

Phase IIIB/IV based on TNM criteria (8th);

At least one measurable tumor based on RECIST 1.1;

Without the known active mutation of EGFR/ALK/ROS1/RET;

Male or female, age=18 or =70 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 healing wound;

No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;

For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;

No history of serious allergic to biologic agents, especially E.Coli products;

The authorized ICF must be signed.

Exclusion Criteria:

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.

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.
• Docetaxel
docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle
• Carboplatin
carboplatin is administered on Day 1 of each 21-day,followed by docetaxol or pemetrexed
• Pemetrexed
pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective response rate based on Recist 1.1 edition	8 weeks
Secondary	PFS	progress free survival	8 weeks