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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Endostar; Drug: Vinorelbine; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.	Radiation: Radiotherapy; Drug: Endostar; 7.5mg/m2, D1-14; Drug: Vinorelbine; 25-30mg/m2, D1,8; Drug: Cisplatin; 25 mg/m2, D1-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor blood volume	3 months
Tumor blood flow	3 months
Permeability-surface area product	3 months
18-FDG PET SUV values	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of adverse events	3 months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Guoliang Jiang, MD, Fudan University; Principal Investigator: Ming Fan, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Cisplatin; Vinorelbine; Endostar protein
• Other Study ID Numbers: NSCLC0901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No