EUCTR2007-004219-75-BG进行中（未招募）不适用
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. - EXPAND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 870
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent before any study-related activities are carried out
- •Age = 18 years
- •Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (AEG types I-III according to Siewert classification, see appendix A)
- •Diagnosis should be based on recently obtained tumor material. The histological sample on which the diagnosis is based must have been obtained no more than 2 years before enrolment into this study.
- •Archived tumor material sample for at least subsequent standardized EGFR expression assessment Investigators must make sure in advance that appropriate archived tumor material is
- •available from a potentially eligible subject, and that a sample can be shipped to a
- •central repository if the subject agrees to participate.
- •Unresectable advanced (M0) or unresectable metastatic (M1) disease. In the event of unresectable advanced disease, at least one measurable locoregional
- •lymph node or other measurable extraluminal tumor lesion = 2cm must be documented (irrespective of whether it is measured by conventional techniques or spiral CT scan).
- •At least one radiographically documented measurable lesion in a previously nonirradiated area according to RECIST, i.e. this lesion must be adequately measurable in at least one dimension (longest diameter to be recorded) as = 2cm by conventional techniques or = 1 cm by spiral CT scan (see section 7.2). Primary tumor site will be considered as a non-measurable lesion only.
- •ECOG performance status 0-1
- •Estimated life expectancy > 12 weeks
- •Medically accepted contraception (if the risk of conception exists)
- •Glomerular filtration rate (GFR) = 60mL/min
- •The GFR is to be based on the Cockroft-Gault formula for creatinine clearance:
- •GFR (mL/min)=(C x (140-age [years] x weight [kg]))/(72 x serum creatinine (mg/dL))
- •where C = 0.85 for female subjects and C = 1.00 for male subjects
- •ASAT = 2.5 x ULN and ALAT = 2.5 x ULN
- •Bilirubin = 3 x ULN
- •ANC = 1.5 x 109/L
- •Platelets = 100 x 109/L
- •Hemoglobin = 10 g/dL (without transfusions)
- •Sodium and potassium within normal limits or = 10% above or below (supplementation permitted)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior chemotherapy. However previous (neo-)adjuvant (radio-)chemotherapy is allowed
- •if it was finished > 1 year prior to start of study treatment and no more than 300 mg/m2
- •cisplatin has been administered
- •Prior treatment with an antibody or molecule targeting EGFR- and/or VEGFR-related
- •signaling pathways
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •Radiotherapy (except localized radiotherapy for pain relief as outlined in section 6.8.2),
- •major surgery or any investigational drug in the 30 days before the start of study
- •Concurrent chronic systemic immune or hormone therapy not indicated in this study
- •protocol (except for physiologic replacement)
- •Clinically relevant coronary artery disease (NYHA functional angina classification
- •III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy,
- •history of myocardial infarction in the last 12 months, or high risk of uncontrolled
- •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
- •- Subjects with 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 NCI-CTCAE grade = 2 and/or ototoxicity
- •NCI-CTC AE grade = 2, except if due to trauma or mechanical impairment due to
- •Pregnancy or lactation period
- •Concurrent treatment with a non-permitted drug (see section 6.8.2)
- •Treatment in another clinical study within the past 30 days
- •Previous malignancy other than gastric cancer in the last 5 years except for basal cell cancer of the skin or preinvasive 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
研究者
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