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

  • China
      • 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
Drug: Recombinant human endostatin
Recombinant human endostatin 7.5mg/m2
Other Names:
  • Endostar
ACTIVE_COMPARATOR: Standard Arm
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
Drug: 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

Peking University Third Hospital

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.

Subscribe