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

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: 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Endostatins Drug: Docetaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Study Start Date : June 2009
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Intervention Details:
  • Drug: Endostatins
    7.5mg/m2 qd *14d,q3w
  • Drug: Docetaxel
    75mg/m2 D1, q3w,4-6cycles

Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: six weeks ]
  2. Progression free survival [ Time Frame: six weeks ]
  3. Overall survival [ Time Frame: three months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: six weeks ]
    EORTC QLQ-C30(v3.0)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01192230


Contacts
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Contact: Jianhua Chang, MD,PhD 13916619284 changjianhua@hotmail.com

Locations
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China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jianhua Chang, MD,PhD    13916619284    changjianhua@hotmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
More Information
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Responsible Party: Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT01192230    
Other Study ID Numbers: EndoDocNSCLC
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: August 2010
Keywords provided by Fudan University:
Objective response rate
Disease control rate
Disease free survival
Overall survival
 Quality of Live
Nonsmall cell lung cancer
toxicity
Additional relevant MeSH terms:
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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
Docetaxel
 Endostatins
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors