Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

NCT ID: NCT03706703

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-09-01

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endostar continuous intravenous infusion

Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin

Group Type: EXPERIMENTAL

Endostar

Intervention Type: DRUG

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

Intervention Type: DRUG

docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle

Carboplatin

Intervention Type: DRUG

carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed

Pemetrexed

Intervention Type: DRUG

pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle

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

Docetaxel

docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle

Intervention Type: DRUG

Carboplatin

carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed

Intervention Type: DRUG

Pemetrexed

pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Chuan Jin, post-graduate

Role: primary

18302078099@163.com

020-66673666

Other Identifiers

ENDOSTAR

Identifier Type: -

Identifier Source: org_study_id