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


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Advanced Esophageal

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

Outcome Time Frame:

within study period

Safety Issue:

Yes

Principal Investigator

Xi-Chun Hu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fu Dan University Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

BT-ESO-T-0901

NCT ID:

NCT00950417

Start Date:

July 2009

Completion Date:

December 2010

Related Keywords:

  • Advanced Esophageal
  • nimotuzumab esophageal chemo-radiotherapy
  • Esophageal Diseases
  • Esophageal Neoplasms

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