NCT00971932已完成2 期
Open-label, Single-arm, Multicenter, Phase II Study Investigating Cetuximab in Combination With Chemotherapy in the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
研究概览
简要总结
The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of SCCHN
- •Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by immunohistochemistry (IHC)
- •Expected survival is more than 6 months
- •Presence of at least 1 bidimensionally measurable lesion either by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- •Recurrent and/or metastatic SCCHN not suitable for local therapy
- •Greater than or equal to (>=) 20 years of age
- •Karnofsky performance status (KPS) >= 70% at trial entry
- •Neutrophils: >= 1500 per millimeter^3 (1,500/mm^3); platelet count >= 100,000/mm^3; and hemoglobin >= 9 gram per deciliter (g/dL)
- •Total bilirubin less than or equal to (<=) 2 * upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 * ULN
- •Creatinine clearance >60 milliliter per minute (mL/min).Calculated based on formulae such as the Cockroft-Gault formula for creatinine clearance
- •Serum calcium within normal range (If serum albumin < 4.0 g/dL, the following adjusted serum calcium concentration should be within normality: Adjusted serum calcium concentration = actual serum calcium (milligram per deciliter [mg/dL]) - 0.8 * [actual serum albumin (g/dL) - 4]
- •Effective contraception if risk of conception exists (applicable for both male and female subjects)
- •Signed written informed consent
- •Japanese (with Japanese citizenship)
排除标准
- •Nasopharyngeal carcinoma
- •Prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
- •Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
- •Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin [HCG] test) or breastfeeding
- •Known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
- •Uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure >= 180 millimeter of mercury [mmHg] and/or diastolic blood pressure >= 130 mmHg under resting conditions) or liver failure
- •Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
- •Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
- •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
- •Current other squamous cell carcinoma (SCC) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
- •Intake of any investigational medication within 30 days before trial entry
- •Other concomitant anticancer therapies
- •Documented or symptomatic brain or leptomeningeal metastasis
- •Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
- •Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or EGFR targeting therapy
- •Legal incapacity or limited legal capacity
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Cetuximab + Cisplatin/Carboplatin + Fluorouracil (5-FU)
Experimental
干预措施: Cetuximab (Drug)
Cetuximab + Cisplatin/Carboplatin + Fluorouracil (5-FU)
Experimental
干预措施: Cisplatin/Carboplatin (Drug)
Cetuximab + Cisplatin/Carboplatin + Fluorouracil (5-FU)
Experimental
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
时间窗: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011
Percentage of participants experiencing a complete response \[CR\] (complete disappearance of measurable and evaluable disease without new lesions) or partial response \[PR\] (greater than or equal to 50 percent decrease in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
次要结局
- Duration of Response(Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011)
- Progression-Free Survival (PFS) Time(Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011)
- Disease Control Rate(Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011)
- Overall Survival (OS) Time(Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011)
- Time to Treatment Failure(Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011)
- Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria(Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011)
研究者
研究点 (3)
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