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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)

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: Endostar
Drug: Vinorelbine
Drug: Cisplatin
Radiation: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Endostar
7.5mg/m2, D1-14
Drug: Vinorelbine
25-30mg/m2, D1,8
Drug: Cisplatin
25 mg/m2, D1-3
Radiation: Radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687439

Locations
China
Fudan University Shanghai Cancer Center
Shanghai, China
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Guoliang Jiang, MD Fudan University
Principal Investigator: Ming Fan, MD Fudan University
  More Information

No publications provided

Responsible Party: Fan Ming, Associate Professor, Fudan University
ClinicalTrials.gov Identifier: NCT01687439     History of Changes
Other Study ID Numbers: NSCLC0901
Study First Received: August 16, 2012
Last Updated: September 18, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013