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

Primary Purpose

Stage IV Esophageal Squamous Cell Carcinoma

Status

Withdrawn

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

About this trial

This is an interventional treatment trial for Stage IV Esophageal Squamous Cell Carcinoma focused on measuring Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The first affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab & nab-paclitaxel & cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival(PFS)

Secondary Outcome Measures

Objective Response Rate

Full Information

NCT ID

NCT02034968

First Posted

January 10, 2014

Last Updated

March 4, 2015

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT02034968

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Withdrawn

Why Stopped

No recruitment

Study Start Date

February 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Esophageal Squamous Cell Carcinoma

Keywords

Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab & nab-paclitaxel & cisplatin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Other Intervention Name(s)

Anti epidermal growth factor receptor antibody h-R3

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival(PFS)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

From date of treatment until the date of progression, assessed up to 2 months

Other Pre-specified Outcome Measures:

Title

Overall survival (OS)

Time Frame

12 months

Title

Adverse events

Description

Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0

Time Frame

During the chemotherapy,an expected average of 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiong Zhao, MD

Organizational Affiliation

The First Affiliated Hospital, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

12. IPD Sharing Statement

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

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