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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01669707
Recruitment Status : Unknown
Verified August 2012 by Liyan Xu, Beijing Chest Hospital.
Recruitment status was:  Recruiting
First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Endostar -Continued Pumping into+GP Drug: Endostar -injecting into +GP Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : April 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: two years ]
  2. Clinical benefit rate (CBR) [ Time Frame: two years ]
  3. Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability [ Time Frame: two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669707


Contacts
Contact: Liyan Xu, MD xuliyan2009@yahoo.cn

Locations
China
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

Responsible Party: Liyan Xu, Chief of Medical Oncology Department, Beijing Chest Hospital
ClinicalTrials.gov Identifier: NCT01669707     History of Changes
Other Study ID Numbers: BeijingCH001
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Liyan Xu, Beijing Chest Hospital:
Endostar
advanced Non-small cell lung cancer
Continued Pumping into vein
Gemcitabine
Carboplatin

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