EUCTR2008-001180-11-DE进行中（未招募）不适用
An Open-label, single-arm, Phase II study to evaluate the efficacy and the feasibility of bevacizumab (Avastin®) based on a FOLFOXIRI regimen until progression in patients with previously untreated metastatic colorectal carcinoma (OPAL-Study)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1.Age >= 18 years and <= 70 years
- •2.Indication:
- •–Histologically confirmed diagnosis of metastatic CRC scheduled to start 1st line chemotherapeutic treat¬ment.
- •–At least 1 measurable lesion of >= 2 cm (conventional technique) and >=1 cm (spiral CT), respectively
- •(according to RECIST criteria), which is primarily not resectable.
- •3.Laboratory parameters:
- •Hematology:
- •–Neutrophils > 1,500/µl
- •–Platelets > 100,000/µl
- •–Hemoglobin >= 9 g/dl or 5.59 mmol/l
- •–INR >=1.5 x ULN and aPTT ? 1.5 x ULN within 7 days prior to treatment start
- •Blood chemistry:
- •–Creatinine clearance > 30 ml/min, serum creatinine < 1.5 x ULN
- •–Serum bilirubin < 1.5 x ULN
- •–Alkaline phosphatase and transaminases < 2.5 x ULN (in case of liver metastases < 5 x ULN)
- •Proteinuria:
- •–Patients with < 2+ proteinuria on dipstick urinalysis.
- •–Patients with >=2+ proteinuria on dipstick urinalysis, who demonstrate < 1.0 g of protein/24 h on 24-h urine
- •collection.
- •4.ECOG performance score 0 – 1.
- •5.Life expectancy > 3 months.
- •6.Willingness to give written informed consent, writ¬ten consent for data protection (legal requirement in
- •Germany: Datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1.Prior chemotherapy for metastatic CRC
- •2.Adjuvant / neoadjuvant chemotherapy or radio-chemotherapy of a non-metastatic malignancy completed < 6
- •months prior to treatment start.
- •3.Concomitant malignancies other than CRC (Patients with curatively treated basal and squamous cell carcinoma
- •of the skin and / or in-situ carcinoma of the cervix are eligible).
- •4.Evidence of current central nervous system (CNS) metastases or spinal cord compression. If clinically
- •indicated, patient must undergo a MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to
- •5.Clinically significant cardiovascular diseases, e.g., uncontrolled hypertension, arrhythmia requiring medication,
- •hemoptoe, cardiovascular accident within the last 6 months before treatment start, unstable angina, congestive
- •heart failure (CHF) NYHA grade III/IV, symptomatic coronary heart disease, myocardial infarction within the
- •last year before treatment start, peripheral arterial disease stage >= II.
- •6.Current or recent serious polyneuropathy (grade >= 1 according to NCI CTCAE v3.0 classification; exception:
- •absence of tendon reflexes).
- •7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment
- •start, or anticipation of the need for major surgical procedure during the course of the study.
- •8.Serious non-healing wound, ulcer or bone fracture.
- •9.Evidence of bleeding diathesis or coagulopathy.
- •10.Hemapoetic diseases.
- •11.Known intra-abdominal inflammatory process or serious gastrointestinal ulceration.
- •12.History of chronic intestinal diseases associated with severe diarrhea.
- •13.Known dihydropyrimidine dehydrogenase (DPD) deficien¬cy.
- •14.Thromboembolic events or severe hemorrhage (>= 6 months before treatment start).
- •15.Known hypersensitivity to the test drug bevacizumab or a compound of the background medication [5-
- •fluorouracil (5-FU), folinic acid (FA; leukovorin), or oxaliplatin, irinotecan].
- •16.Allogen transplants requiring immunosuppressive therapy.
- •17.Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding
- •giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or
- •puts the patient at high risk for treatment-related complications.
- •18.As the following medication(s) can have interactive effects and may interfere with the patient's ability to meet
- •the study requirements, they cannot be administered during the clinical study:
- •–Sorivudin or analog compounds.
- •–Current or recent (within 10 days of first dose of study treatment) treatment with full-dose oral or parenteral
- •anticoagulants or thrombolytic agents (e.g., marcumar therapy) for therapeutic purposes.
- •–Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (> 325 mg/day) or
- •clopidogrel (> 75 mg/day).
- •19.Patients who participate currently in another clinical trial or patients who participated in another clinical trial
- •during the last 30 days prior to enrolment.
- •20.Patients who have participated in this study before.
- •21.Women, lactating, pregnant or of childbearing potential and fertile men not using a highly effective
- •contraceptive method . [Women of childbearing potential must have a negative pregnancy test (serum beta-HCG)
- •within 7 days before the first dose of study drug].
- •22.Patients who are committed to an institution by virtue of an order issued either by the judicial
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