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

This study has been completed.
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: July 11, 2017
Last verified: July 2017
  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 Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles Other: laboratory biomarker analysis Other: CT perfusion imaging Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 ]
    from beginning treatment to progressive disease or the last follow-up


Secondary Outcome Measures:
  • Response rate [ Time Frame: 1 month ]
    complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)

  • overall survival [ Time Frame: 5 years ]
    from date of beginning treatment until date of death

  • treatment related toxicities [ Time Frame: 3 months ]
    radiation-induced esophagitis; radiation-induced pneumonia


Enrollment: 73
Actual Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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.
Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles Other: laboratory biomarker analysis Other: CT perfusion imaging

Detailed Description:

Primary

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).

Secondary

Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.

Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
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

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: July 11, 2017

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

Additional relevant MeSH terms:
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
Etoposide
Etoposide phosphate
Endostatins
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 19, 2017