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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fan Ming, Fudan University
ClinicalTrials.gov Identifier:
NCT01687439
First received: August 16, 2012
Last updated: September 18, 2012
Last verified: September 2012

August 16, 2012
September 18, 2012
December 2008
October 2009   (final data collection date for primary outcome measure)
  • Tumor blood volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Tumor blood flow [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Permeability-surface area product [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 18-FDG PET SUV values [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01687439 on ClinicalTrials.gov Archive Site
The incidence of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)
Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Endostar
    7.5mg/m2, D1-14
  • Drug: Vinorelbine
    25-30mg/m2, D1,8
  • Drug: Cisplatin
    25 mg/m2, D1-3
  • Radiation: Radiotherapy
Experimental: 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.
Interventions:
  • Drug: Endostar
  • Drug: Vinorelbine
  • Drug: Cisplatin
  • Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01687439
NSCLC0901
No
Fan Ming, Fudan University
Fudan University
Not Provided
Principal Investigator: Guoliang Jiang, MD Fudan University
Principal Investigator: Ming Fan, MD Fudan University
Fudan University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP