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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687439
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Information provided by (Responsible Party):
Fan Ming, Fudan University

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Tumor blood volume [ Time Frame: 3 months ]
  2. Tumor blood flow [ Time Frame: 3 months ]
  3. Permeability-surface area product [ Time Frame: 3 months ]
  4. 18-FDG PET SUV values [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01687439

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

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Responsible Party: Fan Ming, Associate Professor, Fudan University Identifier: NCT01687439     History of Changes
Other Study ID Numbers: NSCLC0901
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endostar protein
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors