- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02350361
Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.
January 25, 2015 updated by: Li Liang, Peking University Third Hospital
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking University Third Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Endostar Arm
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14
|
Recombinant human endostatin 7.5mg/m2
Other Names:
|
ACTIVE_COMPARATOR: Standard Arm
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Responese Rate
Time Frame: in two months
|
in two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: up to six months
|
up to six months
|
Overall Survial
Time Frame: follow up every two months, about two years
|
follow up every two months, about two years
|
Number of Serious Adverse Events
Time Frame: within two months
|
within two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Liang, MD, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ANTICIPATED)
July 1, 2015
Study Completion (ANTICIPATED)
March 1, 2016
Study Registration Dates
First Submitted
January 12, 2015
First Submitted That Met QC Criteria
January 25, 2015
First Posted (ESTIMATE)
January 29, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
January 29, 2015
Last Update Submitted That Met QC Criteria
January 25, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUTH-LL01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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