Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

Sponsor

Biotech Pharmaceutical Co., Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT00950417

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Advanced Esophageal	Drug: Nimotuzumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Esophageal Cancer	Drug: Nimotuzumab

Arm

Intervention/Treatment

Experimental: Esophageal Cancer

Drug: Nimotuzumab

Outcome Measures

Primary Outcome Measures

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. [within study period]

Secondary Outcome Measures

To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 aphthosis, 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

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Cancer Hospital	Shanghai	Shanghai	China	200032

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biotech Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT00950417

Other Study ID Numbers:

BT-ESO-T-0901

First Posted:

Jul 31, 2009

Last Update Posted:

Aug 19, 2015

Last Verified:

Jul 1, 2009

Keywords provided by Biotech Pharmaceutical Co., Ltd.

nimotuzumab esophageal chemo-radiotherapy

Additional relevant MeSH terms:

Esophageal Neoplasms

Nimotuzumab

Study Results

No Results Posted as of Aug 19, 2015