EUCTR2010-018993-20-DE进行中（未招募）不适用
Multicenter phase II study of panitumumab, docetaxel, 5-FU, leucovorin and oxaliplatin (P-FLOT) in patients with metastatic or locally advanced Kras wild type adenocarcinoma of the stomach or the gastroesophageal junction
niversitätsklinikum Schleswig-Holstein, Campus Kiel0 个研究点开始时间: 2012年5月16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
- •Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either
- •-distant metastases (TX NX M1) or
- •-locally advanced disease (T3/4 N0 M0) or
- •-stage II / III (> T1 N2 / T2a/b N1)
- •No preceding cytotoxic or targeted therapy (adjuvant treatment allowed if finished = 6 months before inclusion)
- •Patients with confirmed KRAS wildtype
- •At least one unidimensional, measurable tumour parameter according to RECIST
- •Age = 18 years
- •Adequate haematological, hepatic, renal and metabolic function parameters:
- •Leukocytes > 3000/mm³, ANC = 1500/mm3, platelets = 100,000/mm3, Hb > 9g/dl (may be transfused or treated with erythropoietin to maintain or exceed this level)
- •Serum creatinine = 1.5 x upper limit of normal
- •Bilirubin = upper limit of normal, ASAT and ALAT = 2.5 x upper limit of normal. AP = 2,5 upper limit of normal
- •Magnesium = lower limit of normal; calcium = lower limit of normal
- •Written and signed patient consent form
- •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
- •Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, docetaxel, panitumumab
- •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment.
- •History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Known brain metastases
- •Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
- •Other severe internal disease (e.g. insufficiently treated arterial hypertension, other uncontrolled severe disease)
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •Peripheral polyneuropathy > NCI Grade I
- •Chronic inflammatory bowel disease
- •On-treatment participation in a clinical study in the period 30 days prior to inclusion
- •Known her2 neu overexpression defined as either Her2 3+ in immunohistochemistry or 2+ in immunohistochemistry and FISH positivity.
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