NCT02034968

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

January 10, 2014

Last Update Submit

March 4, 2015

Conditions

Stage IV Esophageal Squamous Cell Carcinoma

Keywords

NimotuzumabNab-PaclitaxelCarcinoma of Esophagus

Outcome Measures

Primary Outcomes (1)

  • Progression free survival(PFS)

    12 months

Secondary Outcomes (1)

  • Objective Response Rate

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

Other Outcomes (2)

  • Overall survival (OS)

    12 months

  • Adverse events

    During the chemotherapy,an expected average of 3 weeks

Study Arms (1)

Nimotuzumab & nab-paclitaxel & cisplatin

EXPERIMENTAL

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

Drug: Nimotuzumab

Interventions

NimotuzumabDRUG

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

Also known as: Anti epidermal growth factor receptor antibody h-R3
Nimotuzumab & nab-paclitaxel & cisplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Qiong Zhao, MD

    The First Affiliated Hospital, Zhejiang University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Thoracic Oncology

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

CN(1)