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Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer (DP-EN-RT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Guangdong Medical College
Fujian Province Tumor Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangxi Medical University
Zhejiang Cancer Hospital
Guangzhou General Hospital of Guangzhou Military Command
The 458 Hospital of Chinese PLA
Information provided by (Responsible Party):
Ming Chen, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01218594
First received: June 1, 2010
Last updated: September 17, 2012
Last verified: August 2012
  Purpose

To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Endostatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Response Rate (RR) [ Time Frame: 4 weeks after CCRT ] [ Designated as safety issue: Yes ]
    Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).


Enrollment: 50
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endostatin combine CCRT
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Drug: Endostatin
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Other Name: Endostar

Detailed Description:

OBJECTIVES:

Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT

Secondary

  • The progression-free survival (PFS)
  • The overall survival(OS).
  • The failed treatment modality.
  • The toxicity of this regimen.

OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.

Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.

Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age

    • untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
    • weight loss of less than 10% in the past 6 months
    • performance status (PS) of 0 to 1
    • forced vital capacity in 1 second (FEV1) higher than 0.8 L
    • measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
    • absolute neutrophil count (ANC) of ≥ 1500/μL
    • hemoglobin ≥ 10 mg/dL
    • platelet ≥ 100,000/μL
    • serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
    • calculated creatinine clearance (CrCl) of ≥ 60 ml/min
    • bilirubin 1.5×ULN
    • AST and ALT less than 2.5×ULN
    • alkaline phosphatase less than 5×ULN.

Exclusion Criteria:

  • active infection
  • history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • malnutrition (loss of ≥ 20% of the original body weight)
  • sensor or motor neuropathy > grade I
  • second primary malignancy, except for non-melanoma skin cancer
  • psychiatric illness or social situation that would preclude study compliance
  • pregnant or lactating women
  • preexisting bleeding diatheses or coagulopathy
  • Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
  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: NCT01218594

Locations
China, Guangdong
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Guangdong Medical College
Fujian Province Tumor Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangxi Medical University
Zhejiang Cancer Hospital
Guangzhou General Hospital of Guangzhou Military Command
The 458 Hospital of Chinese PLA
Investigators
Study Chair: Ming Chen, Doctor Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Ming Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01218594     History of Changes
Other Study ID Numbers: DP-EN-RT
Study First Received: June 1, 2010
Results First Received: August 19, 2012
Last Updated: September 17, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Stage III
Unresectable
Non-small cell lung cancer

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
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014