Back to resultsEndostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant human endostatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring endostar, angiogenesis, EGFR-TKI, lung caner
Eligibility Criteria
Inclusion Criteria:
- Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.
- Life expectancy of at least three (3) months after the start of administration of the investigational drug.
- Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.
- Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and >=10 mm.
- Patient received at least 6 months EGFR-TKI and show tumor progress
- Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy
- Patient signed consent form and adherence and geographic location are liable to follow up
Exclusion Criteria:
- CNS metastasis
- Active infection
- Bleeding tendency or blood coagulation dysfunction
- History of neurological or psychiatric disorders, including epilepsy, or dementia
- Pregnancy or breast-feeding women
- Organ transplant long-term use of immunosuppressive drugs
- Arrhythmia need anti-arrhythmic treatment or other risk of heart disease
- Use other targeted drugs during the research
- Other conditions may not allowed to join in this study according to the researcher's judgment
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endostar Arm
Standard Arm
Arm Description
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
Outcomes
Primary Outcome Measures
Objective Responese Rate
Secondary Outcome Measures
Progression Free Survival
Overall Survial
Number of Serious Adverse Events
Full Information
NCT ID
NCT02350361
First Posted
January 12, 2015
Last Updated
January 25, 2015
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02350361
Brief Title
Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
Official Title
A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.
Detailed Description
Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
endostar, angiogenesis, EGFR-TKI, lung caner
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar Arm
Arm Type
Experimental
Arm Description
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14
Arm Title
Standard Arm
Arm Type
Active Comparator
Arm Description
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
Intervention Type
Drug
Intervention Name(s)
Recombinant human endostatin
Other Intervention Name(s)
Endostar
Intervention Description
Recombinant human endostatin 7.5mg/m2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Objective Responese Rate
Time Frame
in two months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
up to six months
Title
Overall Survial
Time Frame
follow up every two months, about two years
Title
Number of Serious Adverse Events
Time Frame
within two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.
Life expectancy of at least three (3) months after the start of administration of the investigational drug.
Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.
Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and >=10 mm.
Patient received at least 6 months EGFR-TKI and show tumor progress
Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy
Patient signed consent form and adherence and geographic location are liable to follow up
Exclusion Criteria:
CNS metastasis
Active infection
Bleeding tendency or blood coagulation dysfunction
History of neurological or psychiatric disorders, including epilepsy, or dementia
Pregnancy or breast-feeding women
Organ transplant long-term use of immunosuppressive drugs
Arrhythmia need anti-arrhythmic treatment or other risk of heart disease
Use other targeted drugs during the research
Other conditions may not allowed to join in this study according to the researcher's judgment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Liang, MD
Phone
13241870816
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Liang, MD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Liang, MD
Phone
13241870816
12. IPD Sharing Statement
Learn more about this trial
Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
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