EUCTR2005-003440-66-SK进行中（未招募）1 期
A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of AZD2171 in Combination with 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination with FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
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
- •For inclusion in the study, patients must fulfil all of the following criteria:
- •Provision of written informed consent.
- •Males or females aged 18 years and older.
- •Histological or cytological confirmation of carcinoma of the colon or rectum.
- •Stage IV (metastatic) disease with one or more measurable lesions at least 10 mm in the longest diameter by spiral computed tomography scan or 20 mm with conventional techniques (RECIST criteria).
- •Patients must have received no prior systemic therapy for metastatic disease, except adjuvant therapy >12 months prior to study entry.
- •World Health Organisation (WHO) Performance score <2.
- •Life expectancy of =12 weeks.
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •Adjuvant therapy within 12 months of study entry.
- •Any unresolved toxicity >CTC grade 2 from previous treatments.
- •Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab and AZD2171.
- •Prior therapy with oxaliplatin within 12 months of study entry.
- •Untreated brain or meningeal metastases. Patients with treated and radiological or clinical evidence of stable brain metastases are eligible if asymptomatic and corticosteroids are not required (patients must have discontinued steroids at least 4 weeks prior to registration).
- •Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count less than or equal to 1.5 x 10 to the power 9/L or platelet count less than or equal to 100 x 10 to the power 9/L or requiring regular blood transfusions to maintain haemoglobin >9 g/dL.
- •Serum bilirubin greater than or equal to 1.5 x upper limit of reference range (ULRR).
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 2.5 x ULRR. If liver metastases are present, ALT or AST >5 x ULRR.
- •Serum creatinine >1.5 x ULRR or a creatinine clearance of less than or equal to 50 mL/min calculated by Cockroft-Gault formula (see Section 4.7.2.2).
- •Greater than +1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart unless urinary protein, <1.5 g in a 24 hour urine collection.
- •Patients with a history of poorly controlled hypertension with resting BP >150/100 mmHg in the presence or absence of a stable regimen of anti hypertensive therapy. Measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2 minute intervals and averaged. If the first 2 diastolic readings differ by more than 5mmHg, then an additional reading should be obtained, and averaged.
- •Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease).
- •Mean QTc with Bazett’s correction >470 msec in screening ECG or history of familial long QT syndrome (as per ICH guideline E14).
- •Recent (<28days) major surgery prior to entry into the study, or a surgical incision that is not fully healed.
- •Significant haemorrhage (>30mls/bleeding episode in previous 3 months), haemoptysis (>5mls/bleeding episode in previous 4weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months.
- •Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication.
- •Known severe hypersensitivity to AZD2171, bevacizumab, oxaliplatin, 5 FU, or leucovorin, or any of the excipients of these products.
- •Other concomitant anti-cancer therapy.
- •History of other malignancies within 5 years except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast or basal or squamous cell skin cancer.
- •History of central nervous disorders or uncontrolled seizures.
- •History of significant gastrointestinal impairment, as judged by the investigator that would significantly affect the absorption of AZD2171.
- •Peripheral neuropathy =CTC grade 2.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies.
- •Previous enrolment or randomisation in the present stud
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