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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Beijing Chest Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Liyan Xu, Beijing Chest Hospital
ClinicalTrials.gov Identifier:
NCT01669707
First received: August 13, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
Endostar
advanced Non-small cell lung cancer
Continued Pumping into vein
Gemcitabine
Carboplatin

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

ClinicalTrials.gov processed this record on November 20, 2014