Clinical trial NCT02034968: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stage IV Esophageal Squamous Cell Carcinoma
Keywords: Nimotuzumab
Nab-Paclitaxel
Carcinoma of Esophagus
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression free survival(PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From date of treatment until the date of progression, assessed up to 2 months
Other outcomes:
measure: Overall survival (OS)
timeFrame: 12 months
measure: Adverse events
timeFrame: During the chemotherapy,an expected average of 3 weeks
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Qiong Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: