NCT01532804终止2 期
A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer
Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2011年7月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.
详细描述
Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:
- Center
- Number of metastatic sites: 1 versus > 1
- Bevacizumab-based first-line therapy: Yes versus No
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven colorectal cancer
- •Resected or asymptomatic primary tumor
- •Metastatic colorectal cancer not eligible for curative surgery
- •No major surgery within four weeks of the start of study treatment
- •At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
- •Disease progression after failure of irinotecan-based chemotherapy
- •Bone metastases are allowed if there is at least one other measurable metastatic site
- •CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
- •WHO PS ≤ 2
- •Platelet count >= 100,000 mm3
- •Hemoglobin > 10g/dl
- •Bilirubin < 1.5 ULN, AST/ALT < 5 ULN
- •Serum creatinine < 1.5 ULN, creatinine clearance > 60 ml/min (Cockcroft)
- •A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
- •Negative pregnancy test in women of childbearing potential
- •Male or female using an effective contraceptive method
- •Absence of known or symptomatic brain metastases
- •Life expectancy > 3 months
- •Informed consent signed prior any study specific procedures
排除标准
- •Prior raltitrexed-based chemotherapy
- •Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
- •Uncontrolled arterial hypertension defined as systolic pressure > 150 mm Hg or diastolic pressure > 100 mm Hg
- •Malignant hypertension or hypertensive encephalopathy
- •Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
- •Hemorrhagic diathesis or significant pathology of coagulation
- •Peripheral neuropathy grade>2 (NCI-CTC v4.0)
- •Hemoptysis < 1 month
- •Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
- •Symptomatic brain metastases or carcinomatous meningitis
- •History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
- •Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.4.0)
- •Known or suspected sensitivity to one of the study drugs
- •Pregnant or breastfeeding women
- •Previous enrollment in an investigational drug study within the last 4 weeks
- •Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)
研究组 & 干预措施
Arm A
Experimental
FOLFOX6 + bevacizumab (D1=D15, 12 cycles)
干预措施: bevacizumab, oxaliplatin and 5FU combination (Drug)
Arm B
Experimental
Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)
干预措施: Bevacizumab, oxaliplatin and raltitrexed combination (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 6 months
DFS is estimated from the date of randomization until the first date of objectively documented event or death
次要结局
- Cost-effectiveness study(6 months)
- Treatment-related toxicity(6 months)
- Objective response rate(Every 9 weeks)
- Overall survival(unk)
- Quality of life by using the quality of life questionnaire score(6 months)
研究者
研究点 (1)
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