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Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02804646
Recruitment Status : Unknown
Verified June 2016 by Anhui Provincial Hospital.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Anhui Provincial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Lung Drug: recombinant human endostatin Drug: pemetrexed plus cisplatin or carboplatin Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: endostar and chemotherapy group
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.
 Drug: recombinant human endostatin
endostar was continuous intravenous transfusion for 7 days，with the dose of 15mg/m2 for one day
Other Name: endostar

Drug: pemetrexed plus cisplatin or carboplatin
the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
Other Name: pemetrexed disodium
Active Comparator: chemotherapy group
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.
 Drug: pemetrexed plus cisplatin or carboplatin
the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
Other Name: pemetrexed disodium


Outcome Measures
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Primary Outcome Measures :
  1. progression free survival [ Time Frame: Throughout the study period，an average of 1.5 year ]

Secondary Outcome Measures :
  1. objective response rate [ Time Frame: Throughout the study period，an average of 1.5 year ]
  2. disease control rate [ Time Frame: Throughout the study period，an average of 1.5 year ]
  3. overall survival [ Time Frame: after the study finished，an average of 2 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804646


Contacts
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Contact: Lejie Cao, professor sycaolejie@163.com
Contact: Nana Hu 493305821@qq.com

Locations
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China, Anhui
Anhui provincial hospital Recruiting
Hefei, Anhui, China, 230000
Contact: Lejie Cao, prefessor       sycaolejie@163.com   
Contact: Nana Hu       493305821@qq.com   
Sponsors and Collaborators
Anhui Provincial Hospital
Investigators
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Principal Investigator: Lejie Cao, professor Anhui Provincial Hospital
More Information
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Responsible Party: Anhui Provincial Hospital
ClinicalTrials.gov Identifier: NCT02804646     History of Changes
Other Study ID Numbers: 20160606
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Anhui Provincial Hospital:
Recombinant human endostatin(Endostar)
Durative transfusion
adenocarcinoma of lung
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Cisplatin
Carboplatin
Pemetrexed
 Endostar protein
Endostatins
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors