Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00950417
First received: July 16, 2009
Last updated: August 10, 2009
Last verified: July 2009
  Purpose

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.


Condition Intervention Phase
Advanced Esophageal
Drug: Nimotuzumab and chemoradiation
Phase 1

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: Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. [ Time Frame: within study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: July 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nimotuzumab and chemoradiation

    Experimental: Nimotuzumab, cisplatin ,5FU

    the chemotherapy treatment:4 cycles of chemotherapy(cisplatin,25 mg/m2/d, day1-3;5-FU 600 mg/m2/d,d1-3) The radiotherapy treatment: A dose of 61.2 Gy will be administered in 34 fractions of 1.8 Gy / day, 5 days a week (a total of 6.8weeks).

    the nimotuzumab treatment:3 levels (100mg/w,200mg/w,400mg/w,weekly,6 weeks)

    Other Name: Nimotuzumab
  Eligibility

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

Inclusion Criteria:

  • Informed consent form signed before performing any of the study's specific procedures.
  • ECOG performance status 0-2.
  • Age > 18 and < 75.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
  • Histologically confirmed diagnosis of locally advanced esophageal.
  • Life expectancy of more than 3 months.
  • Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
  • No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
  • Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Exclusion Criteria:

  • Previous radiotherapy or chemotherapy
  • Pregnant or breast-feeding women
  • Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
  • Evidence of distant metastasis
  • Participation in other clinical trials
  • Patients with aphagosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
  • Uncontrolled psychiatric disease or seizure
  • Patients not fit for the clinical trial judged by the investigators
  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: NCT00950417

Contacts
Contact: Xi-chun Hu 021-64175590

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xichun Hu         
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Xi-Chun Hu Fu Dan University Cancer Hospital
Study Chair: Guo-Liang Jiang Fu Dan University Cancer Hospital
  More Information

No publications provided

Responsible Party: Xichun-Hu, Fudan University
ClinicalTrials.gov Identifier: NCT00950417     History of Changes
Other Study ID Numbers: BT-ESO-T-0901
Study First Received: July 16, 2009
Last Updated: August 10, 2009
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Biotech Pharmaceutical Co., Ltd.:
nimotuzumab esophageal chemo-radiotherapy

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 July 28, 2014