Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endostar continuous intravenous infusion Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin |
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.
Drug: Docetaxel
docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle
Drug: Carboplatin
carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed
Drug: Pemetrexed
pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle
|
Outcome Measures
Primary Outcome Measures
- ORR [8 weeks]
objective response rate based on Recist 1.1 edition
Secondary Outcome Measures
- PFS [8 weeks]
progress free survival
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENDOSTAR