CONKO-008: Oxaliplatin/Folinic acid/5-Fluorouracil (24h ) in combination with Lapatinib as a second line therapy in pancreatic cancer after progression under Gemcitabine mono first line therapy- a phase 1/2 trial - CONKO-008

Charité - Universitätsmedizin Berlin0 个研究点目标入组 18 人开始时间: 2010年1月25日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•histologically proven pancreatic adenocarcinoma
•- only phase 2: metastasized disease
•- Karnofsky performance status >60
•- Progression under Gemcitabine
•- Time of progression to study enrollment not more than 4 weeks
•- measurable disease
•- normal cardiac function (ECG, LVEF > 55%)
•- Age > 18 and legal capacity
•- adequate organ function (bone marrow: neutrophils > 1.5 x109/l, hemoglobin > 10g/dl , platelets> 100x109/l; liver: albumine > 2.5 g/dl, AST/ALT > 3x ULN (>5xULN in case of liver metastasis), renal function: creatinine within normal range or clearance > 60 ml/min according to cockrauft gault

•- preceding radiation
•-preceding erlotinib therapy (only phase 2)
•- pregnancy/breast feeding
•-secondary cancers with exception of basal cell carcinoma of the skin
•- cardiac insufficiency NYHA2-4, myocardial infarctation, instable angina pectoris , PTCA or stenting during last 6 months.
•-cardiac arrhythmia
•- arterial or venous thrombembolic events including stroke, TIA, PRIND, cns bleeding during last 6 months
•- known malabsorption including Crohn disease or ulcerous colitis or preceding surgery which may affect uptake of the substance
•- severe concomitant diseases which could affect study participation according to the investigator
•- participant not willing to take adequate contraception
•- pregnancy
•- known allergies to the used substances
•- lack of compliance
•- need of parallel other tumor therapy like biological, hormonal, immunological, radiation- or chemotherapy
•- patients ordered to be hospitalized by legal decision
•- therapy with a not approved substance during the last 4 weeks need for a concomitant therapy with a substance which could influence metabolism of the test substance

发起方