Back to resultsStudy of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
M2ES
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring M2ES, NSCLC, Phase I Trial, Advanced NSCLC, Recurrent NSCLC
Eligibility Criteria
Inclusion Criteria:
- Aged 18-70 years old;
- Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
- No contraindication for chemotherapy;
- ECOG performance scale 0-2;
- No history of anti-angiogenesis therapy;
- Patients are voluntary to participate and sigh the informed contents.
Exclusion Criteria:
- Concurrent use of other anti-cancer agents;
- Allergic history to M2ES and biological agents;
- Pregnant or breast-feeding women;
- With other malignancy;
- With severe cardiopulmonary disease;
- Uncontrolled brain metastasis patients;
- Other conditions that are regarded for exclusion by the trialists.
Sites / Locations
- Tianjin Medical University Cancer Institude and Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
M2ES combined with chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Adverse events incidence,including severe adverse events incidence
Secondary Outcome Measures
Tumor response rate and disease controlled rate
Full Information
NCT ID
NCT01099124
First Posted
February 24, 2010
Last Updated
January 28, 2013
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01099124
Brief Title
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
Official Title
Single-center, Open Trail of Phase 1 of M2ES With TC Regimen in Advanced NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
M2ES, NSCLC, Phase I Trial, Advanced NSCLC, Recurrent NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M2ES combined with chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
M2ES
Intervention Description
polyethylene glycol rh recombinant endostatin
Primary Outcome Measure Information:
Title
Adverse events incidence,including severe adverse events incidence
Time Frame
one year
Secondary Outcome Measure Information:
Title
Tumor response rate and disease controlled rate
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-70 years old;
Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
No contraindication for chemotherapy;
ECOG performance scale 0-2;
No history of anti-angiogenesis therapy;
Patients are voluntary to participate and sigh the informed contents.
Exclusion Criteria:
Concurrent use of other anti-cancer agents;
Allergic history to M2ES and biological agents;
Pregnant or breast-feeding women;
With other malignancy;
With severe cardiopulmonary disease;
Uncontrolled brain metastasis patients;
Other conditions that are regarded for exclusion by the trialists.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai LI
Organizational Affiliation
Tianjin Medical University Cancer Institude and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institude and Hospital
City
Tianjin
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)
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