EUCTR2009-009928-37-DE进行中（未招募）1 期
Phase 1/2 Studie:CONKO-008Oxaliplatin/Folinsäure/5-Fluorouracil (24h) in Kombination mit Lapatinib in der Zweitlinientherapie des Pankreaskarzinoms nach Progress unter Gemcitabin-Monotherapie - CONKO-008
Charite Universitätsmedizin Berlin0 个研究点目标入组 95 人开始时间: 2009年8月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
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 proven pancreatic adenocarcinoma
- •- Metastatic disease (phase 2 only)
- •- Karnowski PI>60
- •- No other therapy for metastatic pancreatic cancer than Gemcitabine
- •- Time of progression on Gemcitabine not earlier than 4 weeks before
- •- Measurable disease according to RECIST criteria.
- •- Normal cardiac function demonstrated by ECG and echocardiogram
- •(LVEF = 55%)
- •- No symptomatic congestive heart failure
- •- No unstable angina pectoris
- •- No cardiac arrhythmia
- •- Adequate organ function as defined by laboratory values
- •Hematologic ANC (absolute neutrophil count)
- •=> 1,5 x 109/L
- •Hemoglobin => 10 g/dL
- •Platelets => 100 x 109/L
- •Hepatic Albumin =>2.5 g/dL
- •Serum bilirubin <=2 mg/dL/<=3 x ULN (liver metastases)
- •AST and ALT <=1,5 x ULN without liver metastases
- •<=5 x ULN if documented liver metastases
- •RenalSerum Creatinine within range of institution
- •Calculated Creatinine Clearance1 >=60 mL/min
- •(Calculated by the Cockcroft and Gault Method)
- •- Patient has provided written informed consent.
- •- compliance
- •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
- •- Insufficient renal/hepatic/bone marrow function
- •- prior radiation
- •- prior erlotinib therapy
- •- secondary malignancies except for basal cell carcinoma of the skin
- •during the last 5 years
- •- concomittant diseases which would, to the opinion of the investigator,
- •endanger study participation
- •- pregnancy .
- •- Class II, III or IV heart failure as defined by the NYHA functional
- •classification system. Myocardial infarction, unstable angina, cardiac
- •angioplasty or stenting procedure within the last 6 months
- •- arterial or venous thrombosis, including stroke, transient ischemic
- •attack, or cerebrovascular accident [CVA] within the last 6 months
- •- History of malabsorption syndrome, disease significantly affecting
- •gastrointestinal function or major resection of the stomach or small
- •bowel that could affect absorption, distribution, metabolism or
- •excretion of study drugs. Subjects with ulcerative colitis or an
- •unresolved bowel obstruction are also excluded.
- •- Concurrent disease or condition that would make the subject
- •inappropriate for study participation or would interfere with the
- •subject’s safety.
- •- Any psychological, familial, or sociological conditions that do not
- •permit compliance with the protocol.
- •- Requirement of concurrent cancer therapy (chemotherapy, radiation
- •therapy, biologic therapy, immunotherapy, or hormonal therapy) while
- •- Requirement of concurrent treatment with an investigational agent,
- •participation in another clinical trial, or any specifically prohibited
- •medication while on study.
- •- known immediate or delayed hypersensitivity reaction or idiosyncrasy
- •to drugs chemically related to Oxaliplatin, 5-FU, Folinic acid or
研究者
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