EUCTR2004-001696-19-ES进行中（未招募）不适用
Open-label, phase II, multicentre study on cetuximab treatment asfirst-line monotherapy in elderly patients with metastatic colorectalcancer expressing EGFR
Spanish Cooperative Group for Gastrointestinal Tomour therapy0 个研究点目标入组 40 人开始时间: 2005年12月1日最近更新:
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
- 入组人数
- 40
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.
- •·Men and women >69 years.
- •·Histologically confirmed diagnosis of CRC.
- •·Non-resectable and/or non-operable metastatic colorectal carcinoma.
- •·Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.
- •·EGFR expression in the primary tumour and/or at least one of the metastases demonstrated by immunohistochemical analysis prior to study.
- •·Karnofsky functional status > 70% at the time of enrollment in the study.
- •·Life expectancy greater than 3 months.
- •·Patients will not have received chemotherapy for advanced/metastatic disease. ·Patients with the following characteristics will be included: 1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free interval > 12 months following conclusion of treatment. 2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment. 3. De novo diagnosis of disease.
- •·Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) £ 2.5 x ULN (£ 5 x ULN if there are hepatic metastases) and total bilirubin count < 1.5 x ULN.
- •·Proper kidney function, defined as serum creatinine < 1.5 x ULN.
- •·Proper hematological function, defined by neutrophil count >or= 1.5 x 109/l , platelets >or= 100 X 109/l and hemoglobin >or= 9 g/dl.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •·Documented or suspected cerebral and/or leptomeningeal metastases.
- •·Surgery (excluding biopsy for diagnosis) and /or radiotherapy during the 4 weeks prior to inclusion in the study.
- •·Participation in another clinical trial with medication in the past 30 days.
- •·Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy and any other investigational drug.
- •·Prior malignant tumor in the past 5 years, except for history of basal cell skin cancer or pre-invasive cervical cancer.
- •·Any investigational drug during the 4 weeks prior to inclusion.
- •·Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
- •·Prior participation in a study in which treatment with cetuximab may be assigned (whether or not treatment with cetuximab is received).
- •·Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
- •·Evidence of grade 3 or 4 allergic reaction to any treatment components.
- •·Clinically relevant myocardial disease or history of infarction in the past 12 months.
- •·Known abuse of alcohol/drugs.
- •·Legal incapacity or limited legal capacity.
- •·Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
- •·Patients catalogued as delicate or frail” for compliance with any of the following criteria:Dependence in one or more activities of daily life according to the Katz Activity of Daily Living (ADL) scale,or 3 or more comorbid entities based on evaluation of the presence of the following processes: congestive heart failure; valvular heart disease; coronary artery disease; obstructive or restrictive chronic pulmonary disease; cerebrovascular disease; peripheral neuropathies; chronic renal failure; hypertension; diabetes; concomitant neoplasms; collagen vascular diseases; and incapacitating arthritis, or Presence of geriatric syndromes: moderate-severe dementia; delirium in situation of stress (urinary or respiratory infection, angina or drugs); moderate-severe depression that interferes with usual activity of patient; frequent falls (3 or more per month); lack of care (Who could help him or her in the event of an emergency?); urinary incontinence in the absence of stress, infection, diuretics or prostatic hyperplasia; fecal incontinence in the absence of diarrhea or laxatives; osteoporotic fractures of long bones or vertebral crush.
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