Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Collaborators: Beijing Cancer Hospital; Chinese Academy of Medical Sciences; Hebei Fourth Hospital; Jiangsu Cancer Institute & Hospital; RenJi Hospital; The Affiliated Cancer Hospital of Zhengzhou University; West China Hospital
• Treatments: Albumin-Bound Paclitaxel; Cetuximab; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Inpatients or outpatients, ≥ 18 years of age

• Histologically confirmed primary (non-recurrent) ESCC fulfilling one of the following criteria (AJCC Staging System)

• cervical esophageal carcinoma, stage Ⅱ-Ⅲ

• upper thoracic esophageal carcinoma, stage Ⅱ-Ⅲ, or mid-thoracic esophageal carcinoma, stage Ⅱ-Ⅲ,which is medically unfit for surgery, surgery been refused and patient medically able to tolerate chemo-radiation.

• Evidence of unidimensional measurable disease as per Response Evaluation Criteria in Solid Tumours (RECIST).

• ECOG Performance status of 0-1

• Effective contraception for both male and female patients if the risk of conception exists

• Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm^3, platelet count ≥ 100,000 /mm^3, hemoglobin ≥ 9 g/dl

• Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min

• Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT & ALST ≤ 1.5 x ULN

• Tumor tissue available for KRAS biomarker test

• Signed written informed consent prior to study entry

Exclusion Criteria:

• Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery

• Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol

• Multiple primary carcinomas of the esophagus

• Pregnancy (confirmed by serum or urine β-HCG) or lactation period;

• Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease

• Unable to comprehend the study requirements or who are not likely to comply with the study parameters;

• Distant metastasis

• Second malignancy, except for curable non-melanoma skin cancer, cervical cancer in situ, or malignant disease, free for ≥ 5 years

• Known grade 3 or 4 allergic reaction to any of the study treatment