Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

This study is currently recruiting participants.
Verified April 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor:
Collaborator:
The First People's Hospital of Lianyungang
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01368419
First received: June 1, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.


Condition Intervention Phase
Esophageal Cancer
Drug: Endostar
Radiation: Radiotherapy
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: Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: every three months until disease progression ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]
  • Serum VEGF Levels [ Time Frame: at baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Endostar
75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks
Radiation: Radiotherapy
6~15MV X-ray, 2Gy/time,5times/week,6 weeks

  Eligibility

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

Inclusion Criteria:

  • Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer
  • Measurable disease according to RECIST criteria
  • ECOG Performance Status 0-1
  • The length of esophageal carcinoma ≤ 10 cm
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
  • Renal function: Cr ≤ 2.0×UNL
  • Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL

Exclusion Criteria:

  • Pregnant or lactating women
  • Evidence of bleeding diathesis, serious infection
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  • Uncontrollable mental and nervous disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368419

Contacts
Contact: Xiaodong Jiang, MD 86-0518-85605120

Locations
China, Jiangsu
The First People's Hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Xiaodong Jiang, MD    0518-85605120      
Principal Investigator: Xiaodong Jiang, MD         
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
The First People's Hospital of Lianyungang
Investigators
Principal Investigator: Xiaodong Jiang, MD The First People's Hospital of Lianyungang
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01368419     History of Changes
Other Study ID Numbers: Endu-201105
Study First Received: June 1, 2011
Last Updated: April 22, 2013
Health Authority: China:SFDA

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Endostar
Radiotherapy
Esophageal Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014