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临床试验/EUCTR2006-001007-11-IT
EUCTR2006-001007-11-IT进行中（未招募）不适用

OPEN-LABEL, MULTICENTER, PHASE II STUDY OF FIRST- LINE BI-WEEKLY IRINOTECAN, OXALIPLATIN AND INFUSIONAL 5FU/LV (FOLFOXIRI) IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH METASTATIC COLORECTAL CANCER. - FOIB

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST0 个研究点开始时间: 2007年7月10日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

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 confirmed colorectal adenocarcinoma;
  • •Unresectable and measurable metastatic disease (RECIST criteria);
  • •Male or female, aged > 18 years and <= 75 years;
  • •ECOG PS < 2 if aged < 71 years;
  • •ECOG PS = 0 if aged 71-75 years;
  • •Life expectancy of more than 3 months;
  • •Adequate haematological function: ANC >= 1.5 x 109/L; platelets >= 100 x 109/L, Hb >= 9 g/dL;
  • •INR <= 1.5 and aPTT <= 1.5 x ULN within 7 days prior to starting study treatment;
  • •Adequate liver function: serum bilirubin <= 1.5 x ULN; alkaline phosphatase and transaminases <= 2.5 x ULN (in case of liver metastases < 5 x ULN);
  • •Serum Creatinine <= 1.5 x ULN;
  • •Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24- hour urine must demonstrate <= 1 g of protein in 24 hours;
  • •Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
  • •At least 6 weeks from prior radiotherapy and 4 weeks from surgery.
  • •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

  • •Prior palliative chemotherapy;
  • •Prior treatment with bevacizumab;
  • •Bowel obstruction (or subobstruction). History of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea);
  • •Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria;
  • •Presence or history of CNS metastasis;
  • •Active uncontrolled infections; active disseminated intravascular coagulation;
  • •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. Central Venous Access Device (CVAD) for chemotherapy administration inserted within 2 days prior to study treatment start;
  • •Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;
  • •Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (<= 6 months before treatment start), myocardial infarction (<= 6 months before treatment start), unstable angina, NYHA >= grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
  • •Uncontrolled hypertension;
  • •24-hour urine protein > 1 g if dipstick > 2+;
  • •History of thromboembolic or hemorrhagic events within 6 months prior to treatment;
  • •Evidence of bleeding diathesis or coagulopathy;
  • •Serious, non healing wound/ulcer or serious bone fracture;
  • •No therapeutic anticoagulation or antiplatelet agents or NSAID with anti-platelet activity (aspirin <= 325 mg/day allowed);
  • •Pregnancy or lactation;
  • •Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.

研究者

发起方
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST

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