Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma
Primary Purpose
Adenocarcinoma of Lung
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
recombinant human endostatin
pemetrexed plus cisplatin or carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Lung focused on measuring Recombinant human endostatin(Endostar), Durative transfusion, adenocarcinoma of lung
Eligibility Criteria
Inclusion Criteria:
- 1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) non-small cell lung cancer patients,with wild-type EGFR and ALK-negative; 2) According to IASLC2009 new TNM staging of lung cancer stage ⅢB or Ⅳ, previously untreated or relapsed after 1 year of lung cancer resection; 3) have at least one evaluable lesions,according to version 1.1 of the standard in accordance with a judgment RECIST(longest diameter on a spiral CT at least 10mm,on a regular CT longest diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6) expected survival at least 3 months; 7) adequate hematological function: absolute neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than upper limit of normal (ULN); AST and ALT less than 2.5 times upper limit of normal (ULN); alkaline phosphatase less than 5 times the upper limit of normal (ULN); 9) adequate renal function: serum creatinine less than upper limit of normal (ULN) or calculated creatinine clearance at least 60 mL/min; 10) ECG is normal, there is no non-healing wounds on the body; 11) had not received previous treatment anticancer drugs, or had only received for previous non-metastatic tumors adjuvant or neoadjuvant chemotherapy, but when you start to study treatment has ended more than 6 months; 12) have conducted previous surgery patients required to study treatment was started more than four weeks, and the patient had recovered; 13) have an intact uterus in women prior to enrollment in the study must have a negative pregnancy test result (unless it is already 24 months of amenorrhea) within 28 days. If the pregnancy test from the first administration more than seven days, urine pregnancy test is required for authentication (less than 7 days before the first dose); 14) previous to biological agents, particularly E.coli genetically engineered products without serious allergic reactions; 15) signed informed consent.
Exclusion Criteria:
- 1) pregnancy, breast-feeding women, or female patients of childbearing potential but did not take contraceptive measures;2) existing severe acute infection and is not controlled; or purulent and chronic infection, delayed healing wounds; 3) the original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 4) suffering from neurological and psychiatric diseases or mental disorders is not easy to control, poor compliance, and can not be described with treatment responders; primary brain or central nervous metastasis disease has not been controlled, with significant cranial hypertension or neuropsychiatric symptoms; 5) have bleeding tendencies; 6) other researchers believe that patients should not participate in the present trial.
Sites / Locations
- Anhui provincial hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
endostar and chemotherapy group
chemotherapy group
Arm Description
recombinant human endostatin(endostar) injection was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 per one day,every 21 days of a cycle,combined with pemetrexed plus cisplatin or carboplatin.
pemetrexed injection was intravenous with the dose of 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin,without recombinant human endostatin.
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
objective response rate
disease control rate
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02804646
Brief Title
Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma
Official Title
Recombinant Human Endostatin Durative Transfusion Combined With Pemetrexed Plus Cisplatin or Carboplatin in the First-line Treatment of Advanced Lung Adenocarcinoma With Wild-type EGFR or ALK-negative
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to discuss the efficacy and safety of recombinant human endostatin(endostar) durative intravenous transfusion combined with pemetrexed plus cisplatin or carboplatin in the first-line treatment of advanced lung adenocarcinoma with wild-type EGFR or ALK-negative,compared with chemotherapy without endostar.
Detailed Description
With the progress of molecular biology and translational medical research, the treatment of advanced non-small cell lung cancer goes into the era of personalized medicine. Lung adenocarcinoma accounts for about 50% of non-small cell lung cancer.In recent years, although individualized targeted therapy in lung adenocarcinoma progress by leaps and bounds, but the research of wild-type EGFR or ALK-negative lung adenocarcinoma is extremely lag, lack of clinically effective targeted drugs.As time goes on,almost all of the EGFR-TKI treatment of lung adenocarcinoma will be resistant one day,and patients need other treatments, such as chemotherapy.Currently, chemotherapy is still the main treatment for advanced lung adenocarcinoma with EGFR wild-type and unkown.Many researches has reported that:endostar combined with chemotherapy in patients with advanced NSCLC can significantly improve the patient's RR,TTP and did not increase the adverse effects of chemotherapy.Recently,endostar durative intravenous transfusion has been widely accept and use because of the lower toxicity.The purpose of our study was to discuss the efficacy and safety of endostard durative intravenous transfusion combined with chemotherapy.In our study,Patients with Ⅲb/Ⅳ lung adenocarcinoma were divided into two groups randomly,one group was treated with endostar durative intravenous transfusion combined with chemotherapy,while the other group with chemotherapy pemetrexed plus cisplatin or carboplatin only.In the end,PFS,ORR,DCR and OS were compared between these two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Lung
Keywords
Recombinant human endostatin(Endostar), Durative transfusion, adenocarcinoma of lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endostar and chemotherapy group
Arm Type
Experimental
Arm Description
recombinant human endostatin(endostar) injection was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 per one day,every 21 days of a cycle,combined with pemetrexed plus cisplatin or carboplatin.
Arm Title
chemotherapy group
Arm Type
Active Comparator
Arm Description
pemetrexed injection was intravenous with the dose of 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin,without recombinant human endostatin.
Intervention Type
Drug
Intervention Name(s)
recombinant human endostatin
Other Intervention Name(s)
endostar
Intervention Description
endostar was continuous intravenous transfusion for 7 days,with the dose of 15mg/m2 for one day
Intervention Type
Drug
Intervention Name(s)
pemetrexed plus cisplatin or carboplatin
Other Intervention Name(s)
pemetrexed disodium
Intervention Description
the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
Throughout the study period,an average of 1.5 year
Secondary Outcome Measure Information:
Title
objective response rate
Time Frame
Throughout the study period,an average of 1.5 year
Title
disease control rate
Time Frame
Throughout the study period,an average of 1.5 year
Title
overall survival
Time Frame
after the study finished,an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) non-small cell lung cancer patients,with wild-type EGFR and ALK-negative; 2) According to IASLC2009 new TNM staging of lung cancer stage ⅢB or Ⅳ, previously untreated or relapsed after 1 year of lung cancer resection; 3) have at least one evaluable lesions,according to version 1.1 of the standard in accordance with a judgment RECIST(longest diameter on a spiral CT at least 10mm,on a regular CT longest diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6) expected survival at least 3 months; 7) adequate hematological function: absolute neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than upper limit of normal (ULN); AST and ALT less than 2.5 times upper limit of normal (ULN); alkaline phosphatase less than 5 times the upper limit of normal (ULN); 9) adequate renal function: serum creatinine less than upper limit of normal (ULN) or calculated creatinine clearance at least 60 mL/min; 10) ECG is normal, there is no non-healing wounds on the body; 11) had not received previous treatment anticancer drugs, or had only received for previous non-metastatic tumors adjuvant or neoadjuvant chemotherapy, but when you start to study treatment has ended more than 6 months; 12) have conducted previous surgery patients required to study treatment was started more than four weeks, and the patient had recovered; 13) have an intact uterus in women prior to enrollment in the study must have a negative pregnancy test result (unless it is already 24 months of amenorrhea) within 28 days. If the pregnancy test from the first administration more than seven days, urine pregnancy test is required for authentication (less than 7 days before the first dose); 14) previous to biological agents, particularly E.coli genetically engineered products without serious allergic reactions; 15) signed informed consent.
Exclusion Criteria:
1) pregnancy, breast-feeding women, or female patients of childbearing potential but did not take contraceptive measures;2) existing severe acute infection and is not controlled; or purulent and chronic infection, delayed healing wounds; 3) the original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 4) suffering from neurological and psychiatric diseases or mental disorders is not easy to control, poor compliance, and can not be described with treatment responders; primary brain or central nervous metastasis disease has not been controlled, with significant cranial hypertension or neuropsychiatric symptoms; 5) have bleeding tendencies; 6) other researchers believe that patients should not participate in the present trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lejie Cao, professor
Email
sycaolejie@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nana Hu
Email
493305821@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lejie Cao, professor
Organizational Affiliation
Anhui Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui provincial hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lejie Cao, prefessor
Email
sycaolejie@163.com
First Name & Middle Initial & Last Name & Degree
Nana Hu
Email
493305821@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma
We'll reach out to this number within 24 hrs