EUCTR2007-004969-18-IT进行中（未招募）1 期
Open-label, efficacy and safety study of bevacizumab (Avastin) in combination with XELOX (Oxaliplatin plus Xeloda) for the first-line treatment of patients with locallyadvanced or metastatic cancer of the colon or rectum -OBELIX - OBELIX
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
- ROCHE
- 入组人数
- 200
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 or cytologically proven diagnosis of colorectal cancer
- •- Locally advanced or metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease
- •- Age ≥ 18
- •- ECOG Performance Status 0-1 (Appendix III)
- •- Life expectancy of at least 12 weeks
- •- At least one measurable lesion according to RECIST criteria
- •- Neutrophils ≥1.5 x 109/L and Platelets ≥100 x 109/L
- •- Total bilirubin ≤1.5 time the upper-normal limits (UNL) of the Institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) ≤2.5 x UNL, or ≤5 x UNL in case of liver metastases, alkaline phosphatase ≤2.5 x UNL, ≤5 x UNL in case of liver metastases.
- •- Creatinine clearance >50 mL/min or serum creatinine ≤1.5 x UNL
- •- Urine dipstick of proteinuria <2+. Patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate ≤1 g of protein/24 hr.
- •- Written informed consent.
- •- Patients must be accessible for treatment and follow up.
- •- Patients registered on this trial must be treated and followed at the participating Center.
- •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
- •- Radiotherapy to any site within 4 weeks before the study.
- •- Untreated brain metastases or spinal cord compression or primary brain tumours.
- •- History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not
- •controlled with standard medical therapy or history of stroke).
- •- Serious, non-healing wound, ulcer, or bone fracture.
- •- Evidence of bleeding diathesis or coagulopathy.
- •- Uncontrolled hypertension.
- •- 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.
- •- Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.
- •- Chronic, daily treatment with high-dose aspirin (>325 mg/day).
- •- Treatment with any investigational drug within 30 days prior to enrolment.
- •- Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study
- •medications.
- •- Other co-existing malignancies or malignancies diagnosed within the last 5 years.
- •- 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.
- •- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
- •- Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at
- •baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of nonchildbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- •- Symptomatic peripheral neuropathy ≥grade 1 according the NCI Common Toxicity Criteria.
研究者
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