Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma

Stage IV Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02034968
• Other study ID #: ZYTOP1406
• Status: Withdrawn
• Phase: Phase 2
• First received: January 10, 2014
• Last updated: March 4, 2015
• Start date: February 2014
• Est. completion date: January 2017

Study information

• Verified date: March 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.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.

Description:

In the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, Chemotherapy became one of the treatment strategies for advanced esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin for patients with advanced esophageal squamous cell carcinoma.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• 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.

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

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Life expectancy =12 weeks.

• 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.

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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
Nimotuzumab: 200mg,IV once a week during chemotherapy.

Locations

Country	Name	City	State
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
Other	Overall survival (OS)		12 months	No
Other	Adverse events	Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0	During the chemotherapy,an expected average of 3 weeks	Yes
Primary	Progression free survival(PFS)		12 months	No
Secondary	Objective Response Rate		From date of treatment until the date of progression, assessed up to 2 months	No