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Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Zhejiang Cancer Hospital
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences
Fudan University
Beijing Cancer Hospital
Tianjin Medical University Cancer Institute and Hospital
Shandong Cancer Hospital and Institute
Jiangsu Cancer Institute & Hospital
Fujian Cancer Hospital
The First People's Hospital of Lianyungang
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01733589
First received: November 2, 2012
Last updated: December 23, 2012
Last verified: December 2012
  Purpose

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.


Condition Intervention Phase
Stage III Non-small-Cell Lung Cancer
Drug: Recombinant human endostatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining 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 Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 2-year ] [ Designated as safety issue: No ]
    from beginning treatment to progressive disease or the last follow-up


Secondary Outcome Measures:
  • Response rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)

  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    from date of beginning treatment until date of death

  • treatment related toxicities [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    radiation-induced esophagitis; radiation-induced pneumonia


Estimated Enrollment: 72
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant Human Endostatin
All patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60~66Gy in 30~33 fractions for 6~7 weeks.
Drug: Recombinant human endostatin
Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • untreated histologic or cytologic of NSCLC verified
  • inoperable stage IIIA or IIIB NSCLC
  • measurable disease by RECIST
  • 18~70 years of age
  • an ECOG PS of 0 to 1
  • absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
  • serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
  • bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
  • forced vital capacity in 1 second (FEV1) higher than 0.8 L
  • CB6 is normal
  • Written informed consent

Exclusion Criteria:

  • a history of other malignant diseases
  • any contraindications for chemoradiotherapy
  • distant metastasis
  • malignant pleural and/or pericardial effusion
  • pregnant or nursing
  • preexisting bleeding diatheses or coagulopathy
  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: NCT01733589

Contacts
Contact: Ming Chen, M.D. +86 18758875572 gzcm@263.net

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Ming Chen, M.D.    0086-571-88122068    gzcm@263.net   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Chinese Academy of Medical Sciences
Fudan University
Beijing Cancer Hospital
Tianjin Medical University Cancer Institute and Hospital
Shandong Cancer Hospital and Institute
Jiangsu Cancer Institute & Hospital
Fujian Cancer Hospital
The First People's Hospital of Lianyungang
Investigators
Principal Investigator: Ming Chen, M.D. Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01733589     History of Changes
Other Study ID Numbers: [2012]-10-24
Study First Received: November 2, 2012
Last Updated: December 23, 2012
Health Authority: China: Ethics Committee

Keywords provided by Zhejiang Cancer Hospital:
Recombinant human endostatin
Non-small-Cell Lung Cancer
chemoradiotherapy

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