EUCTR2011-003137-33-FI进行中（未招募）不适用
Open-label, single-arm, phase II study of bevacizumab (AVASTIN) in combination with alternating Xeliri and Xelox as first-line treatment of patients with metastatic colorectal cancer - AXOAXI
Pia österlund and Helena Isoniemi0 个研究点目标入组 100 人开始时间: 2011年9月8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
- 入组人数
- 100
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
- •Inclusion criteria
- •1.Patients with histologically confirmed diagnosis of CRC, chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy more than 6 months previously for CRC allowed), who are scheduled to start first line chemotherapy for metastatic disease
- •2.Age ? 18
- •3.Measurable or evaluable metastatic disease
- •4.Performance status ECOG performance status 0-2
- •5.Life expectancy greater than 3 months
- •6.Thrombocytes ? 100’000/?l, neutrophils ? 1’500/µl, Aspartate amino transferase/Alanine amino transferase ? 2.5 ? Upper limit of normal (ULN) (= 5 ? ULN if liver metastases present), Alkaline phosphatase ? 2.5 ? ULN (= 5 ? ULN if liver metastases present), Serum bilirubin ? 1.5 ? ULN, Serum Creatinine ? 1.5 ? ULN, Urine dipstick of proteinuria <2+ (or U-Prot <100mg/dl). Patients discovered to have ?2+ proteinuria on dipstick urinalysis at baseline, must undergo a 24-hour urine collection and must have ? 1 g of protein/24 hr
- •7.Women of childbearing potential must have a negative serum pregnancy test done prior to the administration of bevacizumab. Patient and their partner should have adequate contraception up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
- •8.Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures
- •9.Patient must be able to comply with the protocol
- •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
- •Exclusion criteria
- •1.Prior treatment with first-line chemotherapy for metastatic CRC
- •2.Adjuvant treatment within 6 months
- •3.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
- •4.Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
- •5.Clinical or radiological evidence of CNS metastases
- •6.Past or current history within the last 2 years of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
- •7.Serious non-healing wound or ulcer
- •8.Evidence of bleeding diathesis or coagulopathy
- •9.Uncontrolled hypertension
- •10.Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •11.Treatment with any investigational drug within 30 days prior to enrolment
- •12.Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the treatment or patient at high risk from treatment complications
- •13.Chronic daily intake of aspirin (> 325 mg/day) or clopidogren (> 75 mg/day)
- •14.Pregnancy (positive serum pregnancy test) and lactation
- •15.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
研究者
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