Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title:

Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687439
• Other study ID #: NSCLC0901
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2012
• Last updated: September 18, 2012
• Start date: December 2008
• Est. completion date: October 2009

Study information

• Verified date: September 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically proven inoperable stage IIIb-IV NSCLC

• 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:

• Evidence of bleeding diathesis or coagulopathy

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Endostar
7.5mg/m2, D1-14
• Vinorelbine
25-30mg/m2, D1,8
• Cisplatin
25 mg/m2, D1-3

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor blood volume		3 months	No
Primary	Tumor blood flow		3 months	No
Primary	Permeability-surface area product		3 months	No
Primary	18-FDG PET SUV values		3 months	No
Secondary	The incidence of adverse events		3 months	Yes