Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 14
- 主要终点
- Best Overall Response (BOR) Until Cut-off Date 25 January 2011
研究概览
简要总结
The primary objective of this trial is to assess the antitumor activity and safety profile 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 in Head and Neck (SCCHN) in Asian 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Inpatient
- •Greater than or equal to (>=) 18 years of age
- •Histologically or cytologically confirmed diagnosis of SCCHN
- •Recurrent and/or metastatic SCCHN not suitable for local therapy
- •Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified WHO criteria
- •Karnofsky performance status (KPS) >= 80 percent at trial entry
- •Neutrophils >= 1.5*10^9 per liter (L), platelet count >= 100*10^9 per L, and hemoglobin >= 90 gram per 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 per liter (mcmol/L)
- •Serum calcium within normal range
- •Effective contraception if procreative potential exists (applicable for both male and female subjects)
排除标准
- •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
- •Nasopharyngeal carcinoma
- •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
- •Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
- •Known drug abuse (with the exception of alcohol abuse)
- •Known hypersensitivity or allergic reaction against any of the components of the trial treatment
- •Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- •Previous or current other squamous cell carcinoma (SCC)
- •Evidence of previous other malignancy within the last 5 years
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
- •Intake of any investigational medication within 30 days before trial entry
- •Legal incapacity or limited legal capacity
- •Other significant disease that in the Investigator's opinion would exclude the subject from the trial
研究组 & 干预措施
Cetuximab + Cisplatin + 5-Fluorouracil (5-FU)
干预措施: Cetuximab (Biological)
Cetuximab + Cisplatin + 5-Fluorouracil (5-FU)
干预措施: Cisplatin (Drug)
Cetuximab + Cisplatin + 5-Fluorouracil (5-FU)
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Best Overall Response (BOR) Until Cut-off Date 25 January 2011
时间窗: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011
BOR: 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 of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization \[WHO\] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.
Best Overall Response (BOR) Until Cut-off Date 15 November 2012
时间窗: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012
BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.
次要结局
- Time to Progression (TTP) Until Cut-off Date 25 January 2011(Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011)
- Overall Survival (OS) Time Until Cut-off Date 15 November 2012(Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012)
- Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011(Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011)
- Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012(Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012)
- Time to Progression (TTP) Until Cut-off Date 15 November 2012(Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012)
- Duration of Response Until Cut-off Date 25 January 2011(Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011)
- Duration of Response Until Cut-off Date 15 November 2012(Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012)