NCT00678535已完成3 期
Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 904
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
研究概览
简要总结
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).
Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
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
- •Written informed consent before any study-related activities are carried out
- •Age greater than or equal to (>=) 18 years
- •Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Adenocarcinoma of the gastroesophageal junction [AEG] Types I-III according to Siewert classification)
- •Archived tumor material sample for at least subsequent standardized Epidermal Growth Factor Receptor (EGFR) expression assessment
- •Unresectable advanced (M0) or unresectable metastatic (M1) disease
- •At least one radiographically documented measurable lesion in a previously non-irradiated area according to response evaluation criteria in solid tumors (RECIST). The primary tumor site is to be considered as a non-measurable lesion only
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Estimated life expectancy greater than (>) 12 weeks
- •Medically accepted contraception (if the risk of conception exists)
- •Glomerular filtration rate (GFR) >= 60 milliliter per minute (mL/min) The GFR is based on the Cockcroft-Gault formula for creatinine clearance
- •Aspartate-aminotransferase (ASAT) less than or equal to (=<) 2.5 * upper limit of normal (ULN) and alanine-aminotransferase (ALAT) =< 2.5 *ULN
- •Bilirubin =< 3 * ULN
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9 per liter
- •Platelets >= 100 * 10^9 per liter
- •Hemoglobin >=10 gram per deciliter (g/dL) (without transfusions)
- •Sodium and potassium within normal limits or =< 10 percent above or below (supplementation permitted)
排除标准
- •Prior chemotherapy, however, previous (neo-)adjuvant (radio-) chemotherapy allowed if finished > 1 year prior to start of study treatment and no more than 300 mg/m^2 cisplatin has been administered
- •Prior treatment with an antibody or molecule targeting EGFR and/or Vascular Endothelial Growth Factor Receptor (VEGFR) related signaling pathways
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •Radiotherapy (except localized radiotherapy for pain relief), major surgery or any investigational drug within 30 days before the start of study treatment
- •Concurrent chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement)
- •Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the 12 months before study Screening, or high risk of uncontrolled arrhythmia
- •Active Hepatitis B or C
- •Chronic diarrhea or short bowel syndrome
- •Presence of any contra-indication to treatment with cetuximab, capecitabine and cisplatin including:
- •Known hypersensitivity to capecitabine, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Current treatment with sorivudine or chemically related analogues, such as brivudine
- •Symptomatic peripheral neuropathy National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >= 2 and/or ototoxicity NCI CTCAE Grade >= 2, except if due to trauma or mechanical impairment due to tumor mass
- •Pregnancy or lactation period
- •Concurrent treatment with a non-permitted drug
- •Treatment in another clinical study within 30 days prior to study screening
- •Previous malignancy other than gastric cancer within 5 years prior to study screening, except for basal cell cancer of the skin or pre-invasive cancer of the cervix
- •Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
- •Legal incapacity or limited legal capacity
- •Significant disease which, in the Investigator's opinion, would exclude the subject from the study
研究组 & 干预措施
Cetuximab plus Capecitabine plus Cisplatin
Experimental
干预措施: Cetuximab (Drug)
Cetuximab plus Capecitabine plus Cisplatin
Experimental
干预措施: Capecitabine (Drug)
Cetuximab plus Capecitabine plus Cisplatin
Experimental
干预措施: Cisplatin (Drug)
Capecitabine plus Cisplatin
Active Comparator
干预措施: Capecitabine (Drug)
Capecitabine plus Cisplatin
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments
时间窗: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.
次要结局
- Overall Survival (OS)(Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012))
- Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments(Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012))
- Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012))
- Safety - Number of Participants With Adverse Events (AEs)(Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012))
- Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire(Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012))
研究者
研究点 (2)
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