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Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT01192230
Recruitment Status : Unknown
Verified August 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : September 1, 2010
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE August 4, 2010
First Posted Date  ICMJE September 1, 2010
Last Update Posted Date September 16, 2010
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
  • Response rate [ Time Frame: six weeks ]
  • Progression free survival [ Time Frame: six weeks ]
  • Overall survival [ Time Frame: three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
Quality of Life [ Time Frame: six weeks ]
EORTC QLQ-C30(v3.0)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
Official Title  ICMJE A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Brief Summary The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Endostatins
    7.5mg/m2 qd *14d,q3w
  • Drug: Docetaxel
    75mg/m2 D1, q3w,4-6cycles
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
  • ≥ 18 years old
  • patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
  • At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
  • have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
  • ECOG 0-2
  • Expected life time longer than 3 months
  • Normal laboratory values:

    • leucocyte≥ 4×109/L
    • neutrophil≥ 1.5×109/L
    • platelet≥90×109/L
    • Hemoglobin≥ 9g/L
    • ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
    • serum creatinine<1.5 mg/dl
    • bilirubin <1.5×ULN
  • No allergy to biological drug
  • Sign the consent forms

Exclusion Criteria:

  • Patients who have previously received Docetaxel or anti-VEGF inhibitors
  • Severe symptomatic heart disease
  • Female patients during their pregnant and lactation period, or patients without contraception
  • Severe uncontrolled infection
  • Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
  • Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
  • Patients have accepted other clinical trials
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01192230
Other Study ID Numbers  ICMJE EndoDocNSCLC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
PRS Account Fudan University
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP