Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

This study is currently recruiting participants.
Verified August 2012 by Beijing Chest Hospital
Information provided by (Responsible Party):
Liyan Xu, Beijing Chest Hospital
ClinicalTrials.gov Identifier:
First received: August 13, 2012
Last updated: August 17, 2012
Last verified: August 2012

The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Endostar -Continued Pumping into+GP
Drug: Endostar -injecting into +GP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by Beijing Chest Hospital:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Clinical benefit rate (CBR) [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endostar -Continued Pumping into+GP
Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin
Drug: Endostar -Continued Pumping into+GP
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.
Active Comparator: Endostar -injecting into +GP
Endostar that is injecting into vein with Gemcitabine -Cisplatin
Drug: Endostar -injecting into +GP
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles

Detailed Description:

Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically diagnosed NSCLC;
  2. primary treatment,inoperable stage IIIB/IV NSCLC;
  3. Age of 18-75years; Gender Not Required;
  4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

    liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;

  5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
  6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
  7. No history of serious drug allergy;
  8. Informed consent should be obtained before treatment.

Exclusion Criteria:

  1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
  2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
  3. Serious complications and investigator consider it is unsuited enrolling;
  4. Pregnant or lactating women;
  5. Allergic to research drug;
  6. participating in other experimental trials and receive the treatment in four weeks;
  7. The position that is for observing curative effect have a radiotherapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669707

Contact: Liyan Xu, MD xuliyan2009@yahoo.cn

The Beijing Chest Hospital Recruiting
Beijing, China
Contact: Liyan Xu, MD       xuliyan2009@yahoo.cn   
Principal Investigator: Liyan Xu, MD         
Sponsors and Collaborators
Beijing Chest Hospital
  More Information

No publications provided

Responsible Party: Liyan Xu, Chief of Medical Oncology Department, Beijing Chest Hospital
ClinicalTrials.gov Identifier: NCT01669707     History of Changes
Other Study ID Numbers: BeijingCH001
Study First Received: August 13, 2012
Last Updated: August 17, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Chest Hospital:
advanced Non-small cell lung cancer
Continued Pumping into vein

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 16, 2014