Randomized Phase II Open-Label Controlled Study of EMD 72000 (Matuzumab), in Combination With the Chemotherapy Regimen ECX or the Chemotherapy Regimen ECX Alone as First-line Treatment in Subjects With Metastatic Esophago-Gastric Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Objective Response Assessed by Independent Review Committee
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
- •Metastatic disease
- •Immunohistological evidence of Epidermal Growth Factor Receptor (EGFR) expression from archived tissues
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- •At least 1 measurable lesion (modified World Health Organization criteria)
排除标准
- •Previous chemotherapy, unless neo-adjuvant or adjuvant therapy completed greater than (>) 12 months prior to study treatment
- •Radiotherapy or major surgery within 4 weeks prior to treatment
- •Brain metastases
- •Peripheral neuropathy or ototoxicity greater than or equal to (>/=) Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events Version 3 [NCICTC V3])
- •Abnormal electrocardiogram (ECG)
研究组 & 干预措施
ECX Only
干预措施: Epirubicin (Drug)
ECX Only
干预措施: Capecitabine (Drug)
ECX Only
干预措施: Cisplatin (Drug)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
干预措施: Matuzumab (Drug)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
干预措施: Epirubicin (Drug)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
干预措施: Cisplatin (Drug)
Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab
干预措施: Capecitabine (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response Assessed by Independent Review Committee
时间窗: Baseline up to PD or death due to any cause (up to approximately 3 years)
Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (\>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.
次要结局
- Protein Biomarkers Levels(Baseline up to approximately 3 years)
- Duration of Objective Response Assessed by Independent Review Committee(From first documented objective response to PD or death due to any cause (up to approximately 3 years))
- Percentage of Participants With Anti-Matuzumab Antibodies(Baseline up to approximately 3 years)
- Matuzumab Serum Concentration(Baseline up to approximately 3 years)
- Progression-Free Survival(Baseline up to PD or death due to any cause (up to approximately 3 years))
- Overall Survival (OS)(Baseline until death due to any cause (up to approximately 3 years))
- Best Overall Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) Score(Baseline (Day 1), Post Baseline (Up to 3 Years))