[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100089389":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":28,"responsibleParty":60,"collaborators":27,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":27,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":27,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":90,"whyStopped":27,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":27,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cetuximab+ FOLFOXIRI","EXPERIMENTAL","Cetuximab and Irinotecan, Oxaliplatin, 5FU and Folinic acid",[13],"Drug: Cetuximab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Cetuximab","Dose level Infusion time (h) Dose level unit 1 2 3 4 Cetuximab 2.0 mg\u002Fm² 500 500 500 500 Irinotecan, before oxaliplatin 1.0 mg\u002Fm² 95 125 165 180 Oxaliplatin, with folinic acid 2.0 mg\u002Fm² 85 85 85 85 Folinic acid, with folinic acid 2.0 mg\u002Fm² 400 400 400 400 5-FU Infusion 46.0 mg\u002Fm² 3200 3200 3200 3200",[9],[21],"Cetuximab (C225, Erbitux by Merck)",[23],{"name":24,"affiliation":25,"role":26},"Gunnar Folprecht, Dr.","University Hospital Dresden, Medical Department I","PRINCIPAL_INVESTIGATOR",null,[29,42,51],{"facility":30,"status":27,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":27},"Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik","Dresden","Saxony","01307","Germany","DE",{"type":37,"coordinates":38},"Point",[39,40],13.73832,51.05089,{"lat":40,"lon":39},{"facility":43,"status":27,"city":44,"state":27,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":50,"contacts":27},"Westdeutsches Tumorzentrum, Universitaetsklinikum Essen","Essen","45112",{"type":37,"coordinates":47},[48,49],7.01228,51.45657,{"lat":49,"lon":48},{"facility":52,"status":27,"city":53,"state":27,"zip":54,"country":34,"countryCode":35,"cosmosGeoPoint":55,"geoPoint":59,"contacts":27},"Universitaetsklinik Mannheim GmbH, III. Medizinische Klinik","Mannheim","68167",{"type":37,"coordinates":56},[57,58],8.46694,49.4891,{"lat":58,"lon":57},{"type":27,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":61,"oldOrganization":25},"Gunnar Folprecht","100089389","phase-1-safety-of-cetuximab-and-oxaliplatin5-fufairinotecan-in-first-line-treatment-of-metastatic-colorectal-cancer-100089389",false,"NCT00422773","Safety of Cetuximab and Oxaliplatin\u002F5-FU\u002FFA\u002FIrinotecan in First-Line Treatment of Metastatic Colorectal Cancer","Open Labeled, Multicenter Phase I\u002FII Study Evaluating the Dose Escalation\u002FSafety of Cetuximab and Oxaliplatin\u002F5-FU\u002FFA\u002FIrinotecan as First-Line Treatment of Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Diagnosis of non-resectable, histologically confirmed, epithelial growth factor receptor(EGFR)-positive or negative colorectal cancer\n* WHO Performance status 0 or 1\n* Signed written informed consent\n* ≥ 18 years of age\n* Effective contraception for both male and female subjects if the risk of conception exists\n* Adequate bone marrow function: neutrophil blood cell count (NBC) ≥ 1.5 x 10\\^9\u002FL, platelet count ≥ 100 x 10\\^9\u002FL, hemoglobin ≥ 5.96 mmol\u002FL (10 g\u002FdL)\n* Adequate liver and renal function: bilirubin ≤ 1.5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks; ASAT and ALAT ≤ 5 x UNL; serum creatinine ≤ 1.5 x UNL.\n\nExclusion Criteria:\n\n* Previous exposure to epidermal growth factor receptor-targeting therapy\n* Previous chemotherapy for colorectal cancer except for adjuvant treatment with progression of disease documented \\> 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer\n* Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion.\n* Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy.\n* Investigational agents or participation in clinical trials within 30 days before start of the treatment in study.\n* Clinically relevant coronary disease or myocardial infarction within 12 months before study entry.\n* Peripheral neuropathy \\> CTC (Common Toxicity Criteria)grade I\n* Inflammatory bowel disease\n* Previous malignancy (except for colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)\n* History of severe psychiatric illness\n* Drug or alcohol abuse\n* Known hypersensitivity reaction to any of the components of study treatment\n* Pregnancy (absence to be confirmed by b-hCG (pregnancy-) test) or lactation period\n* Brain metastasis and\u002For leptomeningeal disease (known or suspected)\n* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease","ALL","18 Years",{"count":72,"type":73},21,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE1","PHASE2","The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil (5-FU)\u002Ffolinic acid (FA) as first-line treatment for metastatic colorectal cancer.",[80],"Metastatic Colorectal Cancer",[82,83,84,85,86,87,88,89],"phase I\u002FII","cetuximab","oxaliplatin","irinotecan","5-FU","chemotherapy","dose escalation","safety","COMPLETED","2009-02-26",{"date":93,"type":73},"2009-02-27",{"date":95,"type":27},"2007-01",{"name":5,"class":6},3]