Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma

Stage IV Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02011594
• Other study ID #: ZYTOP1407
• Status: Withdrawn
• Phase: Phase 2
• First received: December 7, 2013
• Last updated: February 11, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.

Description:

We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.

• The sample size estimate: 20 cases per arm.

• Males or females aged =18 years, < 75 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy =12 weeks.

• Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.

• Adequate bone marrow, renal, and liver function are required.

• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

• Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

• Allergy to anti-EGFR antibody.

• Female subjects should not be pregnant or breast-feeding.

• Adequate hematological function: Absolute neutrophil count (ANC) =1.5 x 109/L, and Platelet count =100 x 109/L. Adequate renal function: Serum creatinine = 1.5 x ULN, or = 50 ml/min. Adequate liver function: total bilirubin < 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Stage IV Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Nimotuzumab
400mg Q2W intravenously
• Placebo
Normal saline

Locations

Country	Name	City	State
China	Qiong Zhao	Hangzhou	Zhejiang
China	The first affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (Progression free survival)		12 months	No
Secondary	Objective Response Rate		6 months	No
Secondary	Overall survival (OS)		12 months	No
Secondary	Disease control rate (DCR)		12 months	No