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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192230
First received: August 4, 2010
Last updated: September 15, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Endostatins
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Response rate [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    EORTC QLQ-C30(v3.0)


Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Endostatins
    7.5mg/m2 qd *14d,q3w
    Drug: Docetaxel
    75mg/m2 D1, q3w,4-6cycles
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01192230

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

Locations
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
Principal Investigator: Jianhua Chang, MD,PhD Fudan University affiliated cancer hospital
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University Cancer Hospital, Department of Medical Oncology,Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT01192230     History of Changes
Other Study ID Numbers: EndoDocNSCLC
Study First Received: August 4, 2010
Last Updated: September 15, 2010
Health Authority: China: Food and Drug Administration

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:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014