EUCTR2007-002886-11-IT进行中（未招募）不适用
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE III STUDY OF SECOND-LINE CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB IN METASTATIC COLORECTAL CANCER PATIENTS WHO HAVE RECEIVED FIRST-LINE CHEMOTHERAPY PLUS BEVACIZUMAB - BEBYP
G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST0 个研究点开始时间: 2008年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •#61485; Histologically confirmed colorectal adenocarcinoma; #61485; Unresectable and measurable metastatic disease according to RECIST criteria (40); #61485; Progressive disease after or during first-line chemotherapy for metastatic disease including a fluoropyrimidine-based monotherapy + Bevacizumab or a fluoropyrimidine and irinotecan based doublet + Bevacizumab or a fluoropyrimidine and oxaliplatin based doublet + Bevacizumab. #61485; Progressive disease after more than 3 months of first-line chemotherapy for metastatic disease with a fluoropyrimidine, irinotecan and oxaliplatin triplet (FOLFOXIRI) + Bevacizumab to which the patient had previously responded #61485; Male or female, aged > 18 years and < 75 years; #61485; ECOG PS < 2; #61485; Life expectancy of more than 3 months; #61485; Adequate haematological function: ANC #8805; 1.5 x 109/L; platelets #8805; 100 x 109/L, Hb #8805; 9 g/dL; #61485; INR #8804; 1.5 and aPTT #8804; 1.5 x ULN within 7 days prior to starting study treatment; #61485; Adequate liver function: serum bilirubin #8804; 1.5 x ULN; alkaline phosphatase and transaminases #8804; 2.5 x ULN (in case of liver metastases < 5 x ULN); #61485; Serum Creatinine #8804; 1.5 x ULN; #61485; Urine dipstick for proteinuria < 2+. If urine dipstick is #8805; 2+, 24- hour urine must demonstrate #8804; 1g of protein in 24 hours; #61485; 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- • First-line chemotherapy for metastatic disease without bevacizumab; Prior treatment with Cetuximab or other investigational agents; 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
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