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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostatins
Docetaxel
Sponsored by
Fudan University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer hospital Fudan UniversityRecruiting

Outcomes

Primary Outcome Measures

Response rate
Progression free survival
Overall survival

Secondary Outcome Measures

Quality of Life
EORTC QLQ-C30(v3.0)

Full Information

First Posted
August 4, 2010
Last Updated
September 15, 2010
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01192230
Brief Title
Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
Official Title
A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Objective response rate, Disease control rate, Disease free survival, Overall survival, Quality of Live, Nonsmall cell lung cancer, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Endostatins
Intervention Description
7.5mg/m2 qd *14d,q3w
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75mg/m2 D1, q3w,4-6cycles
Primary Outcome Measure Information:
Title
Response rate
Time Frame
six weeks
Title
Progression free survival
Time Frame
six weeks
Title
Overall survival
Time Frame
three months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
EORTC QLQ-C30(v3.0)
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Chang, MD,PhD
Phone
13916619284
Email
changjianhua@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Chang, MD,PhD
Organizational Affiliation
Fudan University affiliated cancer hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chang, MD,PhD
Phone
13916619284
Email
changjianhua@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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