EUCTR2010-024490-39-IT进行中（未招募）不适用
A phase 2 study of panitumumab in patients withcetuximab-refractory metastatic colorectal cancer - PACER
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点开始时间: 2011年5月26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
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
- •? Pathologic diagnosis of metastatic colorectal adenocarcinoma
- •? A wild-type tumor KRAS gene determined from tumor DNA
- •? Failure from previous treatment with fluoropirimidine, oxaliplatin and irinotecan.
- •Patients may or may not have been treated with bevacizumab.
- •? Documented disease progression following a treatment with cetuximab in patients
- •who showed either an objective response after 8 weeks or stable disease after 16
- •weeks of cetuximab treatment.
- •? Age 18 years
- •? ECOG Performance Status 0-2
- •? Neutrophils ? 1,5 x 109/L, platelets ? 100 x 109/L, and hemoglobin ? 9 g/dL
- •? Bilirubin level < 1.5 x ULN
- •? AST (SGOT) and ALT (SGPT) ? 2.5 x ULN (? 5 x ULN if liver metastasis are
- •? Serum creatinine < 1.5 x ULN
- •? Effective contraception, if the risk of conception exists
- •? Life expectancy of greater than 3 months
- •? Written informed consent
- •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
- •? Symptomatic brain metastasis
- •? Interstitial pneumonitis or pulmonary fibrosis
- •? Any other malignancies within 5 years (except for adequately treated carcinoma
- •in situ of the cervix or non melanoma skin cancer)
- •? Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
- •? Any unstable systemic disease (including active infections, any significant
- •hepatic, renal or metabolic disease), metabolic dysfunction, physical examination
- •finding, or clinical laboratory finding that contraindicates the use of study drugs or
- •render the patient at high risk from treatment complications.
研究者
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