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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034968
Recruitment Status : Withdrawn (No recruitment)
First Posted : January 14, 2014
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Qiong Zhao, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Stage IV Esophageal Squamous Cell Carcinoma Drug: Nimotuzumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma
Study Start Date : February 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Drug: Nimotuzumab
Nimotuzumab: 200mg,IV once a week during chemotherapy.
Other Name: Anti epidermal growth factor receptor antibody h-R3




Primary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: From date of treatment until the date of progression, assessed up to 2 months ]

Other Outcome Measures:
  1. Overall survival (OS) [ Time Frame: 12 months ]
  2. Adverse events [ Time Frame: During the chemotherapy,an expected average of 3 weeks ]
    Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034968


Locations
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China, Zhejiang
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
Investigators
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Principal Investigator: Qiong Zhao, MD The First Affiliated Hospital, Zhejiang University
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Responsible Party: Qiong Zhao, Chief of Department of Thoracic Oncology, Zhejiang University
ClinicalTrials.gov Identifier: NCT02034968    
Other Study ID Numbers: ZYTOP1406
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Qiong Zhao, Zhejiang University:
Nimotuzumab
Nab-Paclitaxel
Carcinoma of Esophagus
Additional relevant MeSH terms:
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Carcinoma
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents