Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01687439
Last Updated: 2012-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2008-12-31
2009-10-31
Brief Summary
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Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
Endostar
7.5mg/m2, D1-14
Vinorelbine
25-30mg/m2, D1,8
Cisplatin
25 mg/m2, D1-3
Radiotherapy
Interventions
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Endostar
7.5mg/m2, D1-14
Vinorelbine
25-30mg/m2, D1,8
Cisplatin
25 mg/m2, D1-3
Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* ECOG PS 0-1
* Life expectancy \> 3 months
* Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL
* Adequate liver function: total bilirubin \<1.5 times the upper limit of normal (ULN); AST and ALT \<2.5 times ULN in patients without liver metastases, \<5 times ULN in patients with liver metastases
* Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine clearance ≥ 50 mL / min and urinary protein \<2+. In patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
* International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN within 7 days before enrollment
* Written informed consent
Exclusion Criteria
* History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
* Previously received chemotherapy and radiotherapy and biological targeted therapy
* Uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mm Hg)
* Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (New York Heart Association class ≥Grade II) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
* Unhealed wounds, active peptic ulcer or fracture
* Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
* Women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (IUD, spermicide barrier birth control device or sterilization) during the study. Male who are unwilling to take effective contraceptive measures during the study
* Participated in other clinical trials within 28 days before the initiation of treatment.
* Allergic to any of the study drugs
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Fan Ming
Associate Professor
Principal Investigators
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Guoliang Jiang, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Ming Fan, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Other Identifiers
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NSCLC0901
Identifier Type: -
Identifier Source: org_study_id