Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

NCT03706703 | Unknown Phase 2

• 1 other identifier: ENDOSTAR
• Study Type: interventional
• Target: 50
• 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate based on Recist 1.1 edition

  8 weeks

Secondary Outcomes (1)

• PFS

  8 weeks

Study Arms (1)

Endostar continuous intravenous infusion

EXPERIMENTAL

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

Drug: Endostar; Drug: Docetaxel; Drug: Carboplatin; Drug: Pemetrexed

Interventions

Endostar 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.

Endostar continuous intravenous infusion

Docetaxel DRUG

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

Endostar continuous intravenous infusion

Carboplatin DRUG

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

Endostar continuous intravenous infusion

Pemetrexed DRUG

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

Endostar continuous intravenous infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

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

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

endostar protein; Docetaxel; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 16, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

CN (1)