EUCTR2009-013099-38-DE进行中（未招募）1 期
Sequential first-line therapy in metastatic colorectal cancer with Capecitabine/FUFA, Irinotecan and Bevacizumab - Capecitabine/FUFA plus Bevacizumab versus Capecitabine/FUFA plus Irinotecan plus Bevacizumab as first-line therapy in metastatic colorectal cancer
Klinikum der Universität München, Anstalt des öffentlichen Rechts vertreten durch den Vorstand0 个研究点目标入组 450 人开始时间: 2010年6月4日最近更新:
适应症
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
- 450
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
入选标准
- •Female and male patients can be included in the trial when all following inclusion criteria are met:
- •- patient's informed consent in written form
- •- histologically confirmed metastatic colorectal cancer
- •- metastases are not resectable or the patient can not or does not wish to undergo surgical treatment
- •- no prior chemotherapy of the metastatic disease
- •- measurable metastases according to RECIST version 1.1 (CT Thorax/Abdomen within 4 weeks before registration)
- •- age = 18 years
- •- ECOG performance status 0-1
- •- Life expectancy > 3 months
- •- Evaluation of the KRAS status (decentralized conduction, result is no requirement at time of inclusion)
- •- patient agrees to asservation of tumor material for the purpose of molecular analyses including determination of the genetic profile of the tumor
- •- time interval to prior adjuvant chemotherapies > 6 months
- •- time interval to prior major surgical interventions, open biopsies or significant traumatic damages = 28 days, to port implantations or minor surgical interventions = 7 days, for placement of CVL = 2 days
- •- women of child bearing potential have to apply adequate contraceptive methods
- •- exclusion of an existing pregnancy
- •- normal cardiac function (LVEF = 55%) confirmed by ECG and echocardiography
- •- patients who do not receive anticoagulation, have to have an INR value < 1.5 ULN and PTT < 1.5 ULN. The application of a therapeutically dosed anticoagulation is allowed, as long as INR- and PTT values are within the therapeutic range and the patient is at least 2 weeks under stable dosage of the anticoagulant.
- •- A continuous medication with ASS up to a dose of 325 mg/day ist allowed. Furthermore, administration of Clopidogrel up to a recommended dose of 75 mg/day or of Ticlopidin up to a recommended dose of 2 x 250 mg/day is allowed. However, a combination of ASS with Clopidogrel or with Ticlopidin is not allowed.
- •- Patients with < 2 + proteinuria in the urine dipstick analysis. A 24 hr urine collection analysis should be done for patients with 2 + proteinuria in the urine dipstick analysis at baseline and proteinuria should be = 1 g per 24 hrs
- •- Patients suffered from thrombosis grade 3-4 (NCI CTCAE Version 4.0) in their medical history must recieve prophylactic anticoagulation
- •- appropriate organ function as defined below:
- •Hematological
- •Neutrophiles = 1.5000/µL
- •Hemoglobin = 9 g/dL
- •Platelets = 100.000/µL
- •Albumin = 2.5 g/dL
- •Serum Bilirubin = 1.5 ULN
- •AST and ALT = 2.5 x ULN
- •= 5.0 x ULN with hepatic metastasis
- •Serum creatinine = 1.5 mg/dL
- •or cacluated Creatinine clearance = 50 mL/min (GFR: Cockroft-Gault)
- •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
排除标准
- •A patient can not be included in the trial, if one of the following criteria is met:
- •- Primarily resectable metastases and patient’s wish to undergo surgical intervention
- •- Heart insufficiency grade III or IV (functional NYHA classification)
- •- Existing concomitant disease or condition, which classifies the patient unsuitable for the trial or would interfere with the patient’s safety
- •- Myocardial infarction, instable angina pectoris, cardiac angioplasty or stent placement within the last 6 months
- •- History of an arterial thromboembolism including stroke, transient ischemic attack or cerebrovascular disease within the last 6 months
- •- Severe bleeding within the last 6 months (excluding tumor bleeding before resection), coagulopathy or bleeding diathesis
- •- Abdominal or tracheo-oesophageal fistulas, gastrointestinal perforations within the last 6 months prior to enrolment into the study
- •- not adequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and /or >100 mmHg diastolic blood pressure) under antihypertensive therapy
- •- History of recurring thromboembolic events (> 1 episode of deep vein thrombosis, peripherally embolism) during the last 2 years
- •- Severe wound healing impairment or ulcerations or bone fractures
- •- Pregnant or lactating patients
- •- any psychological, family related, sociological or geographic occurrence, which does not allow compliance to the study protocol
- •- Additional cancer therapy (chemotherapy, radiation, biological therapy, immunotherapy or hormonal therapy) during the course of the trial
- •- Concomitant treatment with other trial medication, any other explicitly prohibited medication during the course of the trial or participation in another clinical trial
- •- Contraindications for treatment with irinotecan and/or FUFA
- •- Any known immediate or delayed hypersensitivity reaction or idiosyncrasy to pharmaceuticals chemically related to Capecitabine, 5-fluorouracil, folinic acid, Irinotecan or Bevacizumab
- •- Acute or subacute ileus or chronic inflammatory bowel disease
- •- Known glucuronidation defect (Gilbert-Meulengracht-Syndrome)
- •- Untreated brain metastases
- •- Known secondary malignant neoplasm within the last 5 years (excluding basal cell carcinoma or in situ carcinoma of the cervix)
- •- known alcohol or drug abuse
- •- missing or limited legal capacity
研究者
相似试验
进行中（未招募）
不适用
Dosisdichte 1st-line Therapie des metastasierten Mammakarzinoms mit Paclitaxel und liposomalem Doxorubicin (Myocet®)metastasiertes MammakarzinomMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancerEUCTR2005-004234-41-DEOtto-von-Guericke Universität Magdeburg
进行中（未招募）
不适用
Individualised choise of 1.line chemotherapy of metastatic colo-rectal cancer. Can the blood test: TIMP-1 help the doctor to choose the best chemotherapy for the individual patient?Metastatic colon or rectal cancerMedDRA version: 14.1Level: PTClassification code 10027457Term: Metastases to liverSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005495-42-DKKell Osterlind210
进行中（未招募）
1 期
Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IVPatients with metastatic or unresectable, recurrent HNSCCEUCTR2019-003060-42-NOMerck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc200
进行中（未招募）
1 期
Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IVPatients with metastatic or unresectable, recurrent HNSCCEUCTR2019-003060-42-ESMerck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc18
进行中（未招募）
1 期
Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IVPatients with metastatic or unresectable, recurrent HNSCCEUCTR2019-003060-42-GBMerck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc200