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

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostar

Vinorelbine

Cisplatin

Radiotherapy

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor blood volume

Tumor blood flow

Permeability-surface area product

18-FDG PET SUV values

Secondary Outcome Measures

The incidence of adverse events

Full Information

NCT ID

NCT01687439

First Posted

August 16, 2012

Last Updated

September 18, 2012

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01687439

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Endostar

Intervention Description

7.5mg/m2, D1-14

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Intervention Description

25-30mg/m2, D1,8

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

25 mg/m2, D1-3

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Primary Outcome Measure Information:

Title

Tumor blood volume

Time Frame

3 months

Title

Tumor blood flow

Time Frame

3 months

Title

Permeability-surface area product

Time Frame

3 months

Title

18-FDG PET SUV values

Time Frame

3 months

Secondary Outcome Measure Information:

Title

The incidence of adverse events

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guoliang Jiang, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ming Fan, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

Country

China

12. IPD Sharing Statement

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

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