EUCTR2006-000208-17-DE进行中（未招募）不适用
An open-label, non-randomized phase II trial of cetuximab in combination with irinotecan and 5-FU/FA for patients with metastatic gastric cancer
niversity hospital Mainz, I. Medizinische Klinik und Poliklinik, Johannes Gutenberg-Universität0 个研究点目标入组 45 人开始时间: 2006年3月7日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •Signed and dated informed consent before the start of specific protocol procedures;
- •Histologically proven gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction;
- •Measurable metastatic disease according to the RECIST criteria. If locally recurrent disease, it must be associated with at least one measurable lymph node (> 20 mm by CT scan or > 10 mm with spiral CT)
- •Age: 18-75 years;
- •ECOG Performance Status 0-2
- •Life expectancy > 12 weeks;
- •Adequate hematological, hepatic and renal functions
- •At least 4 weeks from surgery
- •Recovery from side effects of any prior therapy;
- •Able to comply with scheduled assessments and with management of toxicity.
- •If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.
- •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
- •Other tumor type than adenocarcinoma (e.g., leiomyosarcoma, lymphoma) or a second cancer except in patients with squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix which has been effectively treated. Patients curatively treated and disease free for at least 5 years will be discussed with the sponsor before inclusion
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- •Any prior palliative chemotherapy, adjuvant (and/or neo-adjuvant) chemotherapy or radiotherapy
- •Concurrent treatment with any other anti-cancer therapy
- •Patients with known brain or leptomeningeal metastasis
- •Hypercalcemia not controlled by bisphosphonates
- •Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis;
- •Other serious illness or medical conditions:
- •-Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry; congestive heart failure NYHA grade 3 and 4;
- •-Current history of chronic diarrhea;
- •-History of significant neurologic or psychiatric disorders including dementia or seizures;
- •-Active uncontrolled infection;
- •-Active disseminated intravascular coagulation;
- •-Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- •Known deficit in DPD
- •Contraindications to the use of atropine
- •Concomitant or within a 4-week period administration of any other experimental drug under investigation
- •Pregnant or lactating women
- •Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR pathway targeting therapy
- •Known allergic/hypersensitivity reaction to any of the components of the treatment
- •Known drug abuse/alcohol abuse.
研究者
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