ISRCTN41540878已完成4 期
A multicentre study using the chemotherapy combination of bi-monthly Xeloda and Eloxatin, with the addition of Avastin, in patients with advanced colorectal cancer
Cancer Trials New Zealand (CTNZ)0 个研究点目标入组 60 人开始时间: 2006年5月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histological/cytological confirmation of colorectal cancer
- •2. Locally recurrent or metastatic disease
- •3. Patient performance status (Eastern Cooperative Oncology Group (ECOG) 0-1
- •4. Creatinine clearance greater than or equal to 50 ml/min assessed by Cockroft-Gault formula. If Cockroft-Gault formula yields less than 50 ml/min, direct measurement of creatinine clearance or glomerular filtration rate may be made according to local practice. Direct measurement must be greater than 50 ml/min.
- •5. 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 per 24 hr
- •6. Laboratory values as follows:
- •Haematology:
- •a. Absolute neutrophil count (ANC) >1.5 x 10^9 /l
- •b. Platelet count >100 x 10^9 /l
- •c. Haemoglobin >9 g/dl (may be transfused to maintain or exceed this level)
- •d. International normalized ratio (INR) <1.5; arterial pulse propagation time (APPT) <1.5 x upper limit of normal (ULN)
- •Biochemistry:
- •a. Total bilirubin <1.5 x ULN; serum total bilirubin <30 µmol/l
- •b. Aspartate aminotransferase (AST) or alanine transaminase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
- •c. Serum creatinine <2.0 mg/dl or 177 µmol/l (see creatinine clearance criteria above)
- •7. Age =18years
- •8. Accessible for treatment and follow up
- •9. Written informed consent
排除标准
- •1. Previous systemic therapy (excluding adjuvant treatment) for advanced colorectal cancer
- •2. Less than six months following last dose of adjuvant systemic therapy
- •3. Current or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational drug study
- •4. Unsuitable for treatment with capecitabine (e.g. fluorouracil [5FU] side effects suggestive of dihydropyrimidine dehydrogenase deficiency; gastrointestinal [GI] disease precluding oral therapy)
- •5. Serious uncontrolled infection
- •6. Unsuitable for treatment with oxaliplatin (e.g. significant neuropathy i.e. greater than grade 1 Common Toxicity Criteria [CTC] criteria)
- •7. Brain and/or leptomeningeal disease
- •8. Pregnant or breastfeeding women
- •9. Concurrent anticancer therapy (any radiation must be completed at least four weeks before registration)
- •10. Other malignancy in previous five years except adequately treated basal cell or squamous cell carcinoma of skin or in-situ carcinoma of the cervix
- •11. Treatment with antiviral agent sorivudine, or related compounds such as brivudine
- •12. Clinically significant and active cerebral vascular disease and/or cerebral vascular accident =6 months prior to registration, myocardial infarction =1 year prior to registration, uncontrollable hypertension whilst receiving chronic medication, unstable angina, New York Heart Association (NYHA) grade 2 or greater congestive heart failure or serious cardiac arrythmia requiring medication
- •13. Major surgery within 28 days prior to treatment commencement or anticipation of the need for major surgical procedure during the course of the study
- •14. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes
- •15. Chronic daily treatment with aspirin (>325 mg/day)
- •16. Serious, non-healing wound, ulcer, or bone fracture
- •17. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- •18. Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any excipients of bevacizumab formulation or to any other study drugs
- •19. Patients unable to swallow oral tablets
研究者
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