Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Best Overall Response (BOR)
研究概览
简要总结
Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects.
Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects.
Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient greater than or equal to (>=) 18 years of age
- •Pathologically proven squamous cell carcinoma arising in the oropharynx, hypopharynx or larynx
- •Stage III or IV disease with an expected survival of at least 12 months
- •Medically suitable to withstand a course of concomitant boost RT
- •Presence of at least 1 bi-dimensionally measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified World Health Organization (WHO) criteria
- •Karnofsky Performance Status (KPS) >=80 at trial entry
- •Neutrophils >=1.5*10^9/Liter (L), platelet count >= 100*10^9/L, hemoglobin >= 90 gram/liter (g/L)
- •Total bilirubin less than or equal to (<=) 2*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3*ULN
- •Serum creatinine <=133 micromole/liter (mcmol/L)
- •Serum calcium within normal range
- •Effective contraception if procreative potential exists (applicable to both male and female subjects)
- •Chinese with Chinese citizenship
- •Signed written informed consent
排除标准
- •Evidence of distant metastatic disease
- •Squamous cell carcinoma arising in the nasopharynx or oral cavity
- •Receipt of prior systemic chemotherapy within the last 3 years
- •Previous surgery for the tumor under study other than biopsy
- •Receipt of prior RT to the head and neck
- •Currently receiving RT as part of a postoperative regimen following primary surgical resection
- •Planned neck dissection after trial RT
- •Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
- •Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
- •Uncontrolled hypertension defined as systolic blood pressure >=180 millimeter of mercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions
- •Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding
- •Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
- •Other concomitant anticancer therapies
- •Documented or symptomatic brain or leptomeningeal metastasis
- •Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- •Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- •Evidence of previous other malignancy within the last 5 years
- •Intake of any investigational medication within 30 days before trial entry
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Best Overall Response (BOR)
时间窗: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit
Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.
次要结局
- Progression-Free Survival (PFS)(Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant)