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

NCT ID: NCT02034968

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-01-31

Brief 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.

Detailed 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.

Conditions

Stage IV Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab & nab-paclitaxel & cisplatin

Nimotuzumab: 200mg,IV once a week during chemotherapy.

Nab-paclitaxel: 125mg/m2,(IV over 30 min) (days 1 and 8) on 21 day cycle

Cisplatin: 75mg/m2,IV on 21 day cycle

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

Nimotuzumab: 200mg,IV once a week during chemotherapy.

Interventions

Nimotuzumab

Nimotuzumab: 200mg,IV once a week during chemotherapy.

Intervention Type: DRUG

Other Intervention Names

Anti epidermal growth factor receptor antibody h-R3

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Zhao

Chief of Department of Thoracic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZYTOP1406

Identifier Type: -

Identifier Source: org_study_id